510(k) K894262
- Device
- RUBELLA ANTIGEN AND CONTROL ANTIGEN
- Applicant
- MICROBIX BIOSYSTEMS, INC.
- 510(k) number
- K894262
- Product code
- GON
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-16
- Date received
- 1989-06-21
- 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
- JANIS FREESTONE
- Address
- Darts Mill Flemington NJ US 08822 08822
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GON #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K880157 | MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST | Syva Co. | 1988-02-04 |
| 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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