510(k) K873572
- Device
- Il 35260, Il Test Amylase Reagent
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K873572
- Product code
- CIJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-20
- Date received
- 1987-09-02
- Regulation
- 862.1070
- Classification name
- Saccharogenic, Amylase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE A LYNA
- Address
- 113 Hartwell Ave. P.O. Box 9113 Lexington MA US 02173 02173
FDA Registration Numbers#
- 3013660430
- 3004493545
- 2939693
- 3021841051
- 2247288
- 1827821
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023396 | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | Pointe Scientific, Inc., | 2002-12-23 |
| K991817 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | 1999-07-22 |
| K980013 | AMYLASE | Ac Biochemicals, Inc. | 1998-02-04 |
| K953211 | AMYLASE (ETHYLIDENE PNGPG7) KIT | Randox Laboratories, Ltd. | 1996-06-21 |
| K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | Emd Chemicals, Inc. | 1995-12-11 |
| K940735 | LIQUID AMYLASE (CNPG3) REAGENT SET | Pointe Scientific, Inc., | 1994-08-01 |
| K940010 | DMA AMYLASE (DEMAND) PROCEDURE | Data Medical Associates, Inc. | 1994-03-11 |
| K931301 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | 1993-10-18 |
| K931141 | BIOTROL AMYLASE CNPG3 | Biotrol, USA, Inc. | 1993-05-26 |
| K882225 | -AMYLASE EPS | Boehringer Mannheim Corp. | 1989-01-03 |
| K873250 | ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL | Roche Diagnostic Systems, Inc. | 1987-10-20 |
| K872831 | BIOTROL ALPHA AMYLASE | Biotrol, USA, Inc. | 1987-09-04 |
| K871943 | D.A.T. (TM) AMYLASE REAGENT | Behring Diagnostics, Inc. | 1987-06-03 |
| K864356 | AMYLASE REAGENT | Trace Scientific , Ltd. | 1987-01-21 |
| K863719 | AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 | Technicon Instruments Corp. | 1986-11-13 |