510(k) K872733
- Device
- FIAX TEST KIT FOR MUMPS-G ANTIBODIES
- Applicant
- WHITTAKER BIOPRODUCTS, INC.
- 510(k) number
- K872733
- Product code
- GRB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-06
- Date received
- 1987-07-09
- 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
- LOUISE M HARRIS
- Address
- 8830 Brigg Ford Rd. Walkersville MD US 21793 21793
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872699 | MUMPS CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | 1987-09-18 |
Legacy Summary#
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FDA Review#
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