510(k) K790772
- Device
- Chemtab
- Applicant
- BOEHRINGER MANNHEIM CORP.
- 510(k) number
- K790772
- Product code
- JIM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-06-15
- Date received
- 1979-04-20
- Regulation
- 862.1340
- Classification name
- Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- 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 JIM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902155 | HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) | Hichem Diagnostics | 1990-06-12 |