510(k) K964257
- Device
- IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K964257
- Product code
- LKL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-24
- Date received
- 1996-10-25
- Regulation
- 866.5420
- Classification name
- Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNETTE HELLIE
- Address
- 200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92622 92622
FDA Registration Numbers#
- 2084025
- 9614373
- 3014325803
- 9610746
- 3012471076
- 2432235
- 9681753
- 2050010
- 9610126
- 1000403749
- 3005333358
- 3014607865
- 2050012
- 3004493545
- 9680746
- 3003741796
- 9610806
- 3019906
Source Documents#
Other 510(k) Records For Product Code LKL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993441 | K-ASSAY ALPHA-1 AG | Kamiya Biomedical Co. | 1999-11-24 |
| K964299 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 |
| K922417 | AL-ACID GLYCOPROTEIN RID KIT | The Binding Site, Ltd. | 1992-08-20 |
| K904175 | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | Reagents Applications, Inc. | 1990-11-13 |
| K884217 | TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN | Technicon Instruments Corp. | 1988-11-04 |
| K873868 | ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) | Unipath , Ltd. | 1987-10-20 |
| K862087 | SANTEST 1AP | Scientific Sales Intl., Inc. | 1986-12-03 |
| K861336 | IAP PLATE TEST | Scientific Sales Intl., Inc. | 1986-04-25 |
| K841734 | TAGO FIFFU-GEN, OROSOMUCOID | Tago, Inc. | 1984-06-01 |
| K831960 | TEST FOR HUMAN ALPHA ONE ACID GLYCO- | Kent Laboratories, Inc. | 1983-07-19 |
Legacy Summary#
summary
FDA Review#
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