Submission Details
| 510(k) Number | K974110 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 1997 |
| Decision Date | December 24, 1997 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
Dec 1997
Decision
54d
Days
Class 2
Risk
About This 510(k) Submission
K974110 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on December 24, 1997, 54 days after receiving the submission on October 31, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.
Device Classification
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7060 |
Manufacturer
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