510(k) K831960
- Device
- TEST FOR HUMAN ALPHA ONE ACID GLYCO-
- Applicant
- KENT LABORATORIES, INC.
- 510(k) number
- K831960
- Product code
- LKL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-07-19
- Date received
- 1983-06-17
- Regulation
- 866.5420
- Classification name
- Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2084025
- 3014607865
- 3014325803
- 9610126
- 9610746
- 3019906
- 2432235
- 3004493545
- 9681753
- 2050012
- 2050010
- 1000403749
- 9610806
- 9680746
- 3012471076
- 3005333358
- 3003741796
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K964257 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | Beckman Instruments, Inc. | 1997-03-24 |
| 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 |
Legacy Summary#
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FDA Review#
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