510(k) K884004
- Device
- RUBEOLA TEST
- Applicant
- GULL LABORATORIES, INC.
- 510(k) number
- K884004
- Product code
- GRE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-12-05
- Date received
- 1988-09-21
- Regulation
- 866.3520
- Classification name
- Antiserum, Fluorescent, Rubeola
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RACHFORD, PHD
- Address
- 1011 E. 4800 S. Salt Lake City UT US 84117 84117
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 |
|---|---|---|---|
| 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 |
| K770687 | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | Microbiological Assoc. | 1977-06-14 |
Legacy Summary#
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FDA Review#
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