RIANEN GENTAMICIN RIA KIT
FDA 510(k) clearance K772425 · decided 1978-01-05
Clearance details
- K-number
- K772425
- Device name
- RIANEN GENTAMICIN RIA KIT
- Applicant
- New England Nuclear
- Decision
- Substantially Equivalent
- Date received
- 1977-12-29
- Decision date
- 1978-01-05
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- DJB
- Device class
- 2
- Regulation number
- 862.3450
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- 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 |
|---|---|---|
| AMES TDA SISOMICIN TEST-CONTROL SERUM (K832792) | Miles Laboratories, Inc. | 1983-09-29 |
| GENTAMICIN TEST PACK-ACA (K831210) | E.I. Dupont DE Nemours & Co., Inc. | 1983-05-25 |
| AMES TDA GENTAMICIN TEST (K821669) | Miles Laboratories, Inc. | 1982-12-15 |
| MRI GENTAMICIN RIA KIT (K812394) | Microanalytic Research, Inc. | 1981-09-08 |
| COAT-A-COUNT GENTAMICIN RIA KIT (K811844) | Diagnostic Products Corp. | 1981-07-10 |
| GAMMA STICK GENTAMICIN RIA KIT (K800537) | Alpha Gamma Laboratory | 1980-04-24 |
| QUANTIMUNE GENTAMICIN RIA GENTAMICIN (K791770) | Bio-Rad | 1979-10-17 |
| FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY (K791547) | Bio-Rad | 1979-10-12 |
| BIOASSAY SYSTEM, MS-2 SERUM (K782049) | Abbott Laboratories | 1979-08-28 |
| AMES TDA/GENTGMICIN (K790584) | Miles Laboratories, Inc. | 1979-06-15 |
| EMIT GENTAMICIN ASSAY (K790829) | Syva Co. | 1979-05-15 |
| RIA KIT, SISOMICIN (K782126) | Diagnostic Products Corp. | 1979-02-15 |
Recalls involving this device
No recalls on record reference this clearance.