510(k) K821249
- Device
- ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS
- Applicant
- ELECTRO-NUCLEONICS LABORATORIES, INC.
- 510(k) number
- K821249
- Product code
- GRE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-30
- Date received
- 1982-04-30
- 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#
- 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 |
| K770687 | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | Microbiological Assoc. | 1977-06-14 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases