510(k) K902155
- Device
- HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
- Applicant
- HICHEM DIAGNOSTICS
- 510(k) number
- K902155
- Product code
- JIM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-06-12
- Date received
- 1990-05-15
- 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#
- Contact
- BENTLEY TAM
- Address
- 231 N. Puente St. Brea CA US 92621 92621
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JIM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K790772 | CHEMTAB | Boehringer Mannheim Corp. | 1979-06-15 |
Legacy Summary#
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FDA Review#
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