510(k) K770687
- Device
- MEASLESVIRUS FLOURE. CONJUGATED ANTISERU
- Applicant
- Microbiological Assoc.
- 510(k) number
- K770687
- Product code
- GRE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-14
- Date received
- 1977-04-13
- Regulation
- 866.3520
- Classification name
- Antiserum, Fluorescent, Rubeola
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1419968
- 1181055
- 3004973408
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884004 | RUBEOLA TEST | Gull Laboratories, Inc. | 1988-12-05 |
| K853067 | FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT | Idt, A Division of Whittaker M.A. Bioproducts | 1985-10-22 |
| K821249 | ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS | Electro-Nucleonics Laboratories, Inc. | 1982-07-30 |