510(k) K872699
- Device
- MUMPS CF ANTIGEN AND CONTROL ANTIGEN
- Applicant
- SITA, INC.
- 510(k) number
- K872699
- Product code
- GRB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-18
- Date received
- 1987-07-07
- Regulation
- 866.3380
- Classification name
- Antiserum, Cf, Mumps Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANIS F CHARLTON
- Address
- Regulatory Affairs Dept. 130 So. Main St. Allentown NJ US 08501 08501
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872733 | FIAX TEST KIT FOR MUMPS-G ANTIBODIES | Whittaker Bioproducts, Inc. | 1987-10-06 |
Legacy Summary#
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FDA Review#
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