510(k) K884382
- Device
- Amylase Test (amyl) Item Number: 65653
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K884382
- Product code
- CIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-11
- Date received
- 1988-10-18
- 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#
- Contact
- ANNA G BENTLEY
- Address
- 480 Democrat Rd. Gibbstown NJ US 08027 08027
FDA Registration Numbers#
- 3011989923
- 1319809
- 3012963943
- 2250051
- 1319681
- 3002642396
- 3000308930
- 9680746
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 |
| 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 |