GENTAMICIN TEST PACK-ACA
FDA 510(k) clearance K831210 · decided 1983-05-25
Clearance details
- K-number
- K831210
- Device name
- GENTAMICIN TEST PACK-ACA
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-14
- Decision date
- 1983-05-25
- Days to decision
- 41 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
+ Add to Predicate Builder ◉ Watch E.I. Dupont DE Nemours & Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| MACRO-VUE TEST, GENTAMICIN (K781674) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-11-15 |
Recalls involving this device
No recalls on record reference this clearance.