Nephelrate Antiserums 1GA
FDA 510(k) K781655 · Antibodies, Inc.
510(k) numberK781655
Submission
- Device name
- Nephelrate Antiserums 1GA
- Applicant
- Antibodies, Inc.
Mchenry, IL, US - Received
- September 27, 1978
- Decision date
- November 8, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFN – Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| K221114 | Immunoglobulin G (IgG)CFN · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 08/02/2023SE |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 09/04/2019SE |
| K191985 | Optilite IgA KitCFN · Special | The Binding Site Group , Ltd. | 08/19/2019SE |
| K191635 | Optilite IgM KitCFN · Special | The Binding Site Group , Ltd. | 07/15/2019SE |
| K191465 | Human IgM Kit for use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 06/27/2019SE |
| K190686 | Optilite IgM CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 05/28/2019SE |
| K183151 | Optilite IgA CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 01/23/2019SE |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentCFN · Traditional | Beckman Coulter, Inc. | 01/09/2017SE |
| K150526 | Optilite IgG4 KitCFN · Traditional | The Binding Site Group , Ltd. | 05/30/2015SE |
More from The Binding Site Group , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K890774 | Giardeia(Tm)KHW · Traditional | 04/04/1989SE |
| K843590 | Detect-A-StrepGTZ · Traditional | 10/30/1984SE |
| K822892 | Cortisol Ria KitCGR · Traditional | 11/01/1982SE |
| K812749 | Ultra-DigLCS · Traditional | 10/19/1981SE |
| K812314 | Crithidna Anti-Dna Test KitDHN · Traditional | 09/01/1981SE |
| K802877 | Amikacin Ria KitKLQ · Traditional | 12/19/1980SE |
| K800743 | Tobramycin Ria KitKLB · Traditional | 04/16/1980SE |
| K791217 | TSH Ria KitJLW · Traditional | 09/04/1979SE |
| K781656 | Nephelrate Antiserums, IggCFN · Traditional | 11/08/1978SE |
| K781654 | Nephelrate Antiperums LGMCFN · Traditional | 11/08/1978SE |
Questions and answers
When was Nephelrate Antiserums 1GA cleared by the FDA?
Nephelrate Antiserums 1GA (K781655) received a 510(k) decision of Substantially Equivalent on November 8, 1978, 42 days after the submission was received.
What is the product code of K781655?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.