Submission Details
| 510(k) Number | K963902 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 1996 |
| Decision Date | November 29, 1996 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
QUANTITATIVE FIBRINOGEN ASSAY
Nov 1996
Decision
63d
Days
Class 2
Risk
About This 510(k) Submission
K963902 is an FDA 510(k) clearance for the QUANTITATIVE FIBRINOGEN ASSAY, a Test, Fibrinogen (Class II — Special Controls, product code GIS), submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on November 29, 1996, 63 days after receiving the submission on September 27, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.
Device Classification
| Product Code | GIS — Test, Fibrinogen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7340 |
Manufacturer
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