510(k) K802038
- Device
- Phenytoin Reagent Test Kit
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K802038
- Product code
- DID
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-10-23
- Date received
- 1980-08-25
- Regulation
- 862.3900
- Classification name
- Bacillus Subtilis Microbiology Assay, Tobramycin
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical 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 DID#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K820773 | EMIT-ST URINE COCAINE METABOLITE ASSAY | Syva Co. | 1982-04-08 |
| K780950 | BIO-MONITOR TOBRAMYCIN | Monitor Science Corp. | 1978-08-14 |
| K780182 | TOBRAMYCIN 125I RIA KIT | New England Nuclear | 1978-02-13 |
| K780048 | AMINOGLYCOSIDE TEST SYSTEM | Nichols Institute Diagnostics | 1978-01-20 |