Enzyme-Immunoassay (Rubella Antibodies)
FDA 510(k) K801098 · Flow Laboratories, Inc.
510(k) numberK801098
Submission
- Device name
- Enzyme-Immunoassay (Rubella Antibodies)
- Applicant
- Flow Laboratories, Inc.
Mchenry, IL, US - Received
- May 9, 1980
- Decision date
- September 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GOL – Antigen, Ha (Including Ha Control), Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code GOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K841174 | Rubella Antibody FluoroimmunoassayGOL · Traditional | Intl. Diagnostic Technology | 06/07/1984SE |
| K834032 | Rubaquick Diagnostic KitGOL · Traditional | Abbott Laboratories | 04/17/1984SE |
| K810309 | Rubella Antibodies Test ReagentsGOL · Traditional | Calbiochem-Behring Corp. | 03/11/1981SE |
| K802508 | Rubelisa Igm Test KitGOL · Traditional | M.A. Bioproducts | 12/18/1980SE |
| K802339 | Eia Rubella-GGOL · Traditional | Beckman Instruments, Inc. | 12/18/1980SE |
| K802102 | Rubella Elisa Reagents Rubella Igg AntiGOL · Traditional | Calbiochem-Behring Corp. | 12/18/1980SE |
| K801667 | Gamma COAT(125 I) Rubella AntibodyGOL · Traditional | Clinical Assays, Inc. | 10/23/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | Ortho Diagnostics, Inc. | 08/20/1980SE |
| K800789 | Rubella Bio-Bead Titration KitGOL · Traditional | Litton Bionetics | 06/30/1980SE |
| K800797 | Macro-Vue Rubella Card TestGOL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/20/1980SE |
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|---|---|---|
| K861897 | Uniskan IIJJQ · Traditional | 07/01/1986SE |
| K862066 | Titertek Microplate Washer S-12JTC · Traditional | 06/05/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | 05/20/1986SE |
| K860762 | Gamma-Free Horse SerumKIS · Traditional | 03/10/1986SE |
| K860752 | Goat Serum (29-391-54)KIS · Traditional | 03/10/1986SE |
| K850908 | Titertek Microittration Equip. Handiwash 110 12CHAJTC · Traditional | 03/25/1985SE |
| K844567 | Titertek Twinreader 78-630-00JJQ · Traditional | 03/21/1985SE |
| K844419 | Titertek Multiskan MSS/340JJQ · Traditional | 03/21/1985SE |
Questions and answers
When was Enzyme-Immunoassay (Rubella Antibodies) cleared by the FDA?
Enzyme-Immunoassay (Rubella Antibodies) (K801098) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 130 days after the submission was received.
What is the product code of K801098?
The FDA product code is GOL – Antigen, Ha (Including Ha Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.