SIGMA PROCEDURE 265-UV
FDA 510(k) clearance K811864 · decided 1981-07-31
Clearance details
- K-number
- K811864
- Device name
- SIGMA PROCEDURE 265-UV
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-01
- Decision date
- 1981-07-31
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- CED
- Device class
- 1
- Regulation number
- 862.1520
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PHOSPHORUS TEST ITEM NUMBER 65416 (K894288) | Em Diagnostic Systems, Inc. | 1989-08-31 |
| EKTACHEM CLINICAL CHEM. SLIDES (K840151) | Eastman Kodak Company | 1984-03-22 |
| BTC URINE LH ASSAY (K833710) | Btc Diagnostics, Inc. | 1984-01-30 |
| PHOSPHORUS IL (K820832) | American Monitor Corp. | 1982-04-15 |
| SANDARE FAST 340 PHOSPHORUS PROCEDURE (K812670) | Sandare Chemical Co., Inc. | 1981-10-02 |
| INORGANIC PHOSPHORUS REAGENTS (K811222) | Connecticut Diagnostics, Ltd. | 1981-05-21 |
| CENTRIFICHEM INORGANIC PHOSPHORUS (K802420) | Union Carbide Corp. | 1980-10-31 |
| CENTRIFICHEM INORGANIC PHOSPHORUS (K790662) | Union Carbide Corp. | 1979-05-15 |
Recalls involving this device
No recalls on record reference this clearance.