AMYLASE (ETHYLIDENE PNGPG7) KIT
FDA 510(k) clearance K953211 · decided 1996-06-21
Clearance details
- K-number
- K953211
- Device name
- AMYLASE (ETHYLIDENE PNGPG7) KIT
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-10
- Decision date
- 1996-06-21
- Days to decision
- 347 days
- Clearance type
- Traditional
- Product code
- CIJ
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Crumlin, IE
- 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 |
|---|---|---|
| AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (K023396) | Pointe Scientific, Inc., | 2002-12-23 |
| ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K991817) | Bayer Corp. | 1999-07-22 |
| AMYLASE (K980013) | Ac Biochemicals, Inc. | 1998-02-04 |
| AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (K951494) | Emd Chemicals, Inc. | 1995-12-11 |
| LIQUID AMYLASE (CNPG3) REAGENT SET (K940735) | Pointe Scientific, Inc., | 1994-08-01 |
| DMA AMYLASE (DEMAND) PROCEDURE (K940010) | Data Medical Associates, Inc. | 1994-03-11 |
| OLYMPUS AMYLASE REAGENT (K931301) | Olympus Corp. | 1993-10-18 |
| BIOTROL AMYLASE CNPG3 (K931141) | Biotrol, USA, Inc. | 1993-05-26 |
| -AMYLASE EPS (K882225) | Boehringer Mannheim Corp. | 1989-01-03 |
| IL 35260, IL TEST AMYLASE REAGENT (K873572) | Instrumentation Laboratory CO | 1987-10-20 |
| ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL (K873250) | Roche Diagnostic Systems, Inc. | 1987-10-20 |
| BIOTROL ALPHA AMYLASE (K872831) | Biotrol, USA, Inc. | 1987-09-04 |
Recalls involving this device
No recalls on record reference this clearance.