BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
FDA 510(k) clearance K893269 · decided 1989-07-20
Clearance details
- K-number
- K893269
- Device name
- BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-02
- Decision date
- 1989-07-20
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- CGS
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|
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| CPK REAGENT (K112416) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-11-09 |
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| CREATINE KINASE LIQUID REAGENT, MODEL C519-440 (K072548) | Teco Diagnostics | 2008-04-18 |
| CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K062737) | Horiba Abx | 2007-06-12 |
| SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (K051648) | Arkray, Inc. | 2006-01-31 |
| OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 (K043202) | Olympus America, Inc. | 2004-12-23 |
| WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA (K021332) | Wiener Laboratories Saic | 2002-07-03 |
Recalls involving this device
No recalls on record reference this clearance.