510(k) K812027
- Device
- KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
- Applicant
- EASTMAN KODAK COMPANY
- 510(k) number
- K812027
- Product code
- CIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-08-03
- Date received
- 1981-07-20
- Regulation
- 862.1070
- Classification name
- Starch-dye Bound Polymer, Amylase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3012963943
- 3002642396
- 2250051
- 3011989923
- 1319809
- 9680746
- 3000308930
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931559 | DMA AMYLASE PROCEDURE | Data Medical Associates, Inc. | 1993-10-28 |
| K924339 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | 1992-10-19 |
| K884382 | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 | Em Diagnostic Systems, Inc. | 1989-01-11 |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1985-03-05 |
| K810584 | PHADEBAS ISOAMYLASE TEST | Pharmacia, Inc. | 1981-05-13 |
| K810669 | PANTRAK E.K. | Calbiochem-Behring Corp. | 1981-03-31 |
| K782032 | UNITEST AMYLASE | Boehringer Mannheim Corp. | 1979-03-02 |
Legacy Summary#
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FDA Review#
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