KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
FDA 510(k) clearance K812027 · decided 1981-08-03
Clearance details
- K-number
- K812027
- Device name
- KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1981-07-20
- Decision date
- 1981-08-03
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- CIW
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, 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 |
|---|---|---|
| DMA AMYLASE PROCEDURE (K931559) | Data Medical Associates, Inc. | 1993-10-28 |
| OLYMPUS AMYLASE REAGENT (K924339) | Olympus Corp. | 1992-10-19 |
| AMYLASE TEST (AMYL) ITEM NUMBER: 65653 (K884382) | Em Diagnostic Systems, Inc. | 1989-01-11 |
| ENZYMATIC ALPHA-AMYLASE REAGENT KIT (K850639) | Bio-Analytics Laboratories, Inc. | 1985-03-05 |
| PHADEBAS ISOAMYLASE TEST (K810584) | Pharmacia, Inc. | 1981-05-13 |
| PANTRAK E.K. (K810669) | Calbiochem-Behring Corp. | 1981-03-31 |
| UNITEST AMYLASE (K782032) | Boehringer Mannheim Corp. | 1979-03-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 a recall (Z-0298-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |