510(k) K811864
- Device
- Sigma Procedure 265-uv
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K811864
- Product code
- CED
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-31
- Date received
- 1981-07-01
- Regulation
- 862.1520
- Classification name
- 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- 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#
- 2032900
- 3014325803
- 3003741796
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CED#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894288 | PHOSPHORUS TEST ITEM NUMBER 65416 | Em Diagnostic Systems, Inc. | 1989-08-31 |
| K840151 | EKTACHEM CLINICAL CHEM. SLIDES | Eastman Kodak Company | 1984-03-22 |
| K833710 | BTC URINE LH ASSAY | Btc Diagnostics, Inc. | 1984-01-30 |
| K820832 | PHOSPHORUS IL | American Monitor Corp. | 1982-04-15 |
| K812670 | SANDARE FAST 340 PHOSPHORUS PROCEDURE | Sandare Chemical Co., Inc. | 1981-10-02 |
| K811222 | INORGANIC PHOSPHORUS REAGENTS | Connecticut Diagnostics, Ltd. | 1981-05-21 |
| K802420 | CENTRIFICHEM INORGANIC PHOSPHORUS | Union Carbide Corp. | 1980-10-31 |
| K790662 | CENTRIFICHEM INORGANIC PHOSPHORUS | Union Carbide Corp. | 1979-05-15 |