OLYMPUS CK-MB REAGENT
FDA 510(k) clearance K971817 · decided 1997-06-11
Clearance details
- K-number
- K971817
- Device name
- OLYMPUS CK-MB REAGENT
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-16
- Decision date
- 1997-06-11
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- JLB
- Device class
- 1
- Regulation number
- 862.1210
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PICCOLO METLYTE 7 REAGENT DISC (K992140) | Abaxis, Inc. | 1999-08-26 |
| UNITEST CREATINE KINASE (K782156) | Boehringer Mannheim Corp. | 1979-03-02 |
Recalls involving this device
No recalls on record reference this clearance.