PANCREATIC A-AMYLASE EPS
FDA 510(k) clearance K895880 · decided 1989-12-19
Clearance details
- K-number
- K895880
- Device name
- PANCREATIC A-AMYLASE EPS
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-10-05
- Decision date
- 1989-12-19
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- CIL
- Device class
- 2
- Regulation number
- 862.1160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| SYSTEMATE CALCIUM TEST TECHNICON RA 1000 (K922953) | Em Diagnostic Systems, Inc. | 1992-09-09 |
| ENZYMATIC CO2 (K833724) | American Monitor Corp. | 1983-12-29 |
| CO2 CONTENT (K800111) | American Monitor Corp. | 1980-02-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |