510(k) K871228
- Device
- ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2
- Applicant
- MICROSCAN DIV. BAXTER HEALTHCARE CORP.
- 510(k) number
- K871228
- Product code
- GQS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-26
- Date received
- 1987-03-27
- Regulation
- 866.3400
- Classification name
- Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD G TAYLOR
- Address
- 2040 Enterprise Blvd. West Sacramento CA US 95691 95691
FDA Registration Numbers#
- 3003750284
- 3031590640
- 8010096
- 3013530901
- 1528450
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GQS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093415 | D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-12-23 |
| K943557 | IMAGEN | Dako Diagnostics , Ltd. | 1995-01-09 |
| K905385 | P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN | Virion (U.S.), Inc. | 1991-03-21 |
| K884193 | PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT | Baxter Diagnostics, Inc. | 1988-11-22 |
| K884194 | PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT | Baxter Diagnostics, Inc. | 1988-11-22 |
| K871232 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| K871234 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 |
| K843665 | PARAINFLUENZA 1 | Institute Virion , Ltd. | 1985-09-26 |
| K843667 | PARAINFLUENZA 3 | Institute Virion , Ltd. | 1985-09-26 |
| K802935 | PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR | Orion Diagnostica, Inc. | 1980-12-31 |
Legacy Summary#
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FDA Review#
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