510(k) K880157
- Device
- MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST
- Applicant
- SYVA CO.
- 510(k) number
- K880157
- Product code
- GON
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-04
- Date received
- 1988-01-13
- Regulation
- 866.3510
- Classification name
- Antigen, Cf (including Cf Control), Rubella
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROGERS, JR.
- Address
- 900 Arastradero Rd. P.O. Box 10058 Palo Alto CA US 94303 94303
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GON #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894262 | RUBELLA ANTIGEN AND CONTROL ANTIGEN | Microbix Biosystems, Inc. | 1989-10-16 |
| K802937 | RUBELLA VIRUS ANTIGENS & CONTROLS | Orion Diagnostica, Inc. | 1980-12-31 |
| K802939 | HERPES SIMPLEX TYPE I | Orion Diagnostica, Inc. | 1980-12-31 |
| K780996 | RUBELISA TEST KIT | Microbiological Assoc. | 1978-11-22 |
Legacy Summary#
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FDA Review#
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