510(k) K770564
- Device
- URIC ACID TEST KIT
- Applicant
- Mallinckrodt Critical Care
- 510(k) number
- K770564
- Product code
- CDH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-03
- Date received
- 1977-03-24
- Regulation
- 862.1775
- Classification name
- Acid, Uric, Phosphotungstate Reduction
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
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 CDH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K850933 | URIC ACID | Dilab, Inc. | 1985-06-25 |
| K841067 | URIC ACID REAGENT SET | Medical Specialties, Inc. | 1984-05-01 |
| K821213 | URIC ACID REAGENT SET | Omega Medical Electronics | 1982-07-13 |
| K813076 | PHOSPHOTUNGSTATE REDUCTION, URIC ACID | American Monitor Corp. | 1981-11-16 |
| K810088 | URIC ACID (TPTZ) COLORINMETRIC | Bio-Analytics Laboratories, Inc. | 1981-01-28 |
| K800672 | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC | Diagnostic Solutions, Inc. | 1980-05-28 |
| K800190 | STANBIO DIRECT URIC ACID TEST SET #0770 | Stanbio Laboratory | 1980-02-13 |
| K792403 | ELVI URIC ACID-COLORIMETRIC METHOD | Volu Sol Medical Industries | 1979-12-07 |
| K792412 | ELVI URIC ACID | Volu Sol Medical Industries | 1979-12-07 |
| K790019 | SERUM, URIC ACID DETERMINATION | Fisher Scientific Co., LLC | 1979-02-26 |
| K772082 | ENZAC URIC ACID 100-TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-11-28 |
| K771842 | URIC ACID | Gamma Enterprises, Inc. | 1977-10-25 |
| K770459 | URIC ACID PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-04-29 |
| K760477 | REAGENTS-4 FOR URIC ACID DETERMINATION | Simmler & Son, Inc. | 1976-10-29 |