Submission Details
| 510(k) Number | K894951 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 20, 1989 |
| Decision Date | October 24, 1989 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
Cleared
Traditional
MODIFIED HEMOGLOBIN REAGENT SET
Oct 1989
Decision
96d
Days
Class 2
Risk
About This 510(k) Submission
K894951 is an FDA 510(k) clearance for the MODIFIED HEMOGLOBIN REAGENT SET, a Cyanomethemoglobin (Class II — Special Controls, product code GKK), submitted by Macomb Biotechnology, Inc. (Romeo, US). The FDA issued a Cleared decision on October 24, 1989, 96 days after receiving the submission on July 20, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.
Device Classification
| Product Code | GKK — Cyanomethemoglobin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7500 |
Manufacturer
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