Measlesvirus Floure. Conjugated Antiseru
FDA 510(k) K770687 · Microbiological Assoc.
510(k) numberK770687
Submission
- Device name
- Measlesvirus Floure. Conjugated Antiseru
- Applicant
- Microbiological Assoc.
Mchenry, IL, US - Received
- April 13, 1977
- Decision date
- June 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GRE – Antiserum, Fluorescent, Rubeola
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3520
- Specialty
- Microbiology
Other 510(k)s with product code GRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884004 | Rubeola TestGRE · Traditional | Gull Laboratories, Inc. | 12/05/1988SE |
| K853067 | Fiax Test Kit for Measles-G Antibodies FlyorescentGRE · Traditional | Idt, A Division of Whittaker M.A. Bioproducts | 10/22/1985SE |
| K821249 | Eni Antibody to Measles(Rubeola) VirusGRE · Traditional | Electro-Nucleonics Laboratories, Inc. | 07/30/1982SE |
More from Electro-Nucleonics Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K792133 | Rubelisa Test KitGOK · Traditional | 01/11/1980SE |
| K791397 | Herpes Eia Test KitGQM · Traditional | 09/24/1979SE |
| K781549 | Toxelisa Test KitGLZ · Traditional | 12/07/1978SE |
| K780996 | Rubelisa Test KitGON · Traditional | 11/22/1978SE |
| K781392 | Cytomegilish Test KitGOK · Traditional | 10/24/1978SE |
| K781143 | Immunofluorescence Test Kit · Traditional | 08/14/1978SE |
| K770764 | Tissue Culture Media W/Hepes BufferKIT · Traditional | 07/21/1977SE |
Questions and answers
When was Measlesvirus Floure. Conjugated Antiseru cleared by the FDA?
Measlesvirus Floure. Conjugated Antiseru (K770687) received a 510(k) decision of Substantially Equivalent on June 14, 1977, 62 days after the submission was received.
What is the product code of K770687?
The FDA product code is GRE – Antiserum, Fluorescent, Rubeola, a Class I (low risk) device regulated under 21 CFR 866.3520.