Goat Anti-Rubella Antisera
FDA 510(k) K780010 · Northeast Biomedical Labs., Inc.
510(k) numberK780010
Submission
- Device name
- Goat Anti-Rubella Antisera
- Applicant
- Northeast Biomedical Labs., Inc.
Mchenry, IL, US - Received
- January 3, 1978
- Decision date
- January 20, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GOK – Antisera, Hai (Including Hai Control), Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code GOK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832228 | Rubascan Latex Card TestGOK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/29/1983SE |
| K810835 | Rubazyme - MGOK · Traditional | Abbott Laboratories | 05/05/1981SE |
| K792635 | Antibody to Rubella VirusGOK · Traditional | Electro-Nucleonics Laboratories, Inc. | 03/19/1980SE |
| K792133 | Rubelisa Test KitGOK · Traditional | Microbiological Assoc. | 01/11/1980SE |
| K790122 | RubanonGOK · Traditional | Organon, Inc. | 02/15/1979SE |
| K781638 | Rubindex*Direct SystemGOK · Traditional | Ortho Diagnostics, Inc. | 12/20/1978SE |
| K781392 | Cytomegilish Test KitGOK · Traditional | Microbiological Assoc. | 10/24/1978SE |
| K780063 | RubenosticonGOK · Traditional | Organon, Inc. | 01/20/1978SE |
| K771957 | Rubella Hemagglutination Reagent KitGOK · Traditional | Flow Laboratories, Inc. | 10/28/1977SE |
| K771956 | Human O BufferGOK · Traditional | Flow Laboratories, Inc. | 10/28/1977SE |
More from Flow Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K780697 | Goat Anti-Influenza Antisera AtexasGNS · Traditional | 05/03/1978SE |
| K780696 | Goat Antiinfluenza Antisera AussrGNS · Traditional | 05/03/1978SE |
| K780009 | Guinea Pig Whole SerumKIS · Traditional | 01/20/1978SE |
| K780008 | Goat Anti-Influenza AntiseraGQT · Traditional | 01/20/1978SE |
| K780007 | Goat Anti-Influenza AntiseraGQQ · Traditional | 01/20/1978SE |
| K780006 | Goat Anti-Influenza AntiseraGNS · Traditional | 01/20/1978SE |
| K780005 | Goat Anti-Influenza AntiseraGNS · Traditional | 01/20/1978SE |
| K780004 | Goat Anti-Influenza AntiseraGNS · Traditional | 01/20/1978SE |
Questions and answers
When was Goat Anti-Rubella Antisera cleared by the FDA?
Goat Anti-Rubella Antisera (K780010) received a 510(k) decision of Substantially Equivalent on January 20, 1978, 17 days after the submission was received.
What is the product code of K780010?
The FDA product code is GOK – Antisera, Hai (Including Hai Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.