510(k) K931559
- Device
- DMA AMYLASE PROCEDURE
- Applicant
- DATA MEDICAL ASSOCIATES, INC.
- 510(k) number
- K931559
- Product code
- CIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-10-28
- Date received
- 1993-03-30
- Regulation
- 862.1070
- Classification name
- Starch-dye Bound Polymer, Amylase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNETTE WELLS
- Address
- 845 Ave. G E. Arlington TX US 76011 76011
FDA Registration Numbers#
- 3012963943
- 3002642396
- 2250051
- 3011989923
- 1319809
- 9680746
- 3000308930
- 1319681
Source Documents#
Other 510(k) Records For Product Code CIW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K812027 | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) | Eastman Kodak Company | 1981-08-03 |
| 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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