510(k) K800537
- Device
- GAMMA STICK GENTAMICIN RIA KIT
- Applicant
- ALPHA GAMMA LABORATORY
- 510(k) number
- K800537
- Product code
- DJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-04-24
- Date received
- 1980-03-10
- Regulation
- 862.3450
- Classification name
- Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DJB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832792 | AMES TDA SISOMICIN TEST-CONTROL SERUM | Miles Laboratories, Inc. | 1983-09-29 |
| K831210 | GENTAMICIN TEST PACK-ACA | E.I. Dupont DE Nemours & Co., Inc. | 1983-05-25 |
| K821669 | AMES TDA GENTAMICIN TEST | Miles Laboratories, Inc. | 1982-12-15 |
| K812394 | MRI GENTAMICIN RIA KIT | Microanalytic Research, Inc. | 1981-09-08 |
| K811844 | COAT-A-COUNT GENTAMICIN RIA KIT | Diagnostic Products Corp. | 1981-07-10 |
| K791770 | QUANTIMUNE GENTAMICIN RIA GENTAMICIN | Bio-Rad | 1979-10-17 |
| K791547 | FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY | Bio-Rad | 1979-10-12 |
| K782049 | BIOASSAY SYSTEM, MS-2 SERUM | Abbott Laboratories | 1979-08-28 |
| K790584 | AMES TDA/GENTGMICIN | Miles Laboratories, Inc. | 1979-06-15 |
| K790829 | EMIT GENTAMICIN ASSAY | Syva Co. | 1979-05-15 |
| K782126 | RIA KIT, SISOMICIN | Diagnostic Products Corp. | 1979-02-15 |
| K781674 | MACRO-VUE TEST, GENTAMICIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-11-15 |
| K780516 | GENTAMICIN RIA KIT | Antibodies, Inc. | 1978-04-28 |
| K772116 | AMINOGLYCOSIDE TEST SYSTEM | Nichols Institute Diagnostics | 1978-04-28 |
| K780323 | QUANTITOPE 125-I GENTAMICIN RIA KIT | Kallestad Laboratories, Inc. | 1978-03-17 |
Legacy Summary#
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FDA Review#
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