ULTRA ZYME PLUS GPT, #64956, 65035 & 36 — Harleco (510(k) K812591)
ULTRA ZYME PLUS GPT, #64956, 65035 & 36 — Harleco (510(k) K812591) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ULTRA ZYME PLUS GPT, #64956, 65035 & 36; Applicant: Harleco; Clearance track: 510(k).
| Device name | ULTRA ZYME PLUS GPT, #64956, 65035 & 36 |
|---|---|
| Applicant | Harleco |
| Clearance track | 510(k) |
| Submission number | K812591 |
| Decision | Substantially Equivalent |
| Decision date | 1981-09-24 |
| Date received | 1981-09-11 |
| Product code | CKA |
| Device class | 1 |
| Medical specialty | Clinical Chemistry |
| Applicant location | IL, US |
| Source | openFDA device |
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