510(k) K812313
- Device
- SANDARE URIC ACID PROCEDURE
- Applicant
- SANDARE CHEMICAL CO., INC.
- 510(k) number
- K812313
- Product code
- LFQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-01
- Date received
- 1981-08-17
- Regulation
- 862.1775
- Classification name
- Acid, Uric, Acid Reduction Of Ferric Ion
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007301207
- 3004145393
- 3015413132
- 3003902721
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K860111 | URIC ACID REAGENT SET | Technostics Intl. | 1986-02-19 |
| K860142 | URIC ACID REAGENT SET (COLORIMETRIC) | Sterling Diagnostics, Inc. | 1986-02-11 |
| K844075 | URIC ACID REAGENT SET | Livonia Diagnostics, Inc. | 1984-10-30 |
| K811764 | URIC ACID REAGENT SET | Anco Medical Reagents & Assoc. | 1981-08-20 |
Legacy Summary#
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FDA Review#
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