P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN
FDA 510(k) clearance K905385 · decided 1991-03-21
Clearance details
- K-number
- K905385
- Device name
- P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN
- Applicant
- Virion (U.S.), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-30
- Decision date
- 1991-03-21
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- GQS
- Device class
- 1
- Regulation number
- 866.3400
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Morristown, NJ, 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 |
|---|---|---|
| D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (K093415) | Diagnostic Hybrids, Inc. | 2009-12-23 |
| IMAGEN (K943557) | Dako Diagnostics , Ltd. | 1995-01-09 |
| PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT (K884194) | Baxter Diagnostics, Inc. | 1988-11-22 |
| PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT (K884193) | Baxter Diagnostics, Inc. | 1988-11-22 |
| ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (K871234) | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (K871228) | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (K871232) | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| PARAINFLUENZA 1 (K843665) | Institute Virion , Ltd. | 1985-09-26 |
| PARAINFLUENZA 3 (K843667) | Institute Virion , Ltd. | 1985-09-26 |
| PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (K802935) | Orion Diagnostica, Inc. | 1980-12-31 |
Recalls involving this device
No recalls on record reference this clearance.