BIO-MONITOR TOBRAMYCIN
FDA 510(k) clearance K780950 · decided 1978-08-14
Clearance details
- K-number
- K780950
- Device name
- BIO-MONITOR TOBRAMYCIN
- Applicant
- Monitor Science Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-09
- Decision date
- 1978-08-14
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- DID
- Device class
- 2
- Regulation number
- 862.3900
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Monitor Science Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| EMIT-ST URINE COCAINE METABOLITE ASSAY (K820773) | Syva Co. | 1982-04-08 |
| PHENYTOIN REAGENT TEST KIT (K802038) | Beckman Instruments, Inc. | 1980-10-23 |
| TOBRAMYCIN 125I RIA KIT (K780182) | New England Nuclear | 1978-02-13 |
| AMINOGLYCOSIDE TEST SYSTEM (K780048) | Nichols Institute Diagnostics | 1978-01-20 |
Recalls involving this device
No recalls on record reference this clearance.