GAMMADAB[125]EGE Radioimmunoassay It
FDA 510(k) K821092 · Clinical Assays, Inc.
510(k) numberK821092
Submission
- Device name
- GAMMADAB[125]EGE Radioimmunoassay It
- Applicant
- Clinical Assays, Inc.
Mchenry, IL, US - Received
- April 19, 1982
- Decision date
- June 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| K832712 | Folate Radioassay Kit CA-1562-125CGN · Traditional | 10/04/1983SE |
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| K832710 | Vitamin B12 Radioassay Kit CA-1534CDD · Traditional | 10/04/1983SE |
| K823476 | Gammadab LH Radio-Kit #CA-1508CEP · Traditional | 12/28/1982SE |
| K823313 | In Vitro Gammacoat B-Hcg Radio. TestJHI · Traditional | 12/22/1982SE |
| K821611 | Gammadab [125] FSH Radioimmunay KitCGJ · Traditional | 06/24/1982SE |
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| K810722 | Gastrin Radioimmunoassay TestCGC · Traditional | 05/27/1981SE |
| K810967 | In-Vitro TBG Radioimmunoassay TestCEE · Traditional | 04/23/1981SE |
| K801667 | Gamma COAT(125 I) Rubella AntibodyGOL · Traditional | 10/23/1980SE |
Questions and answers
When was GAMMADAB[125]EGE Radioimmunoassay It cleared by the FDA?
GAMMADAB[125]EGE Radioimmunoassay It (K821092) received a 510(k) decision of Substantially Equivalent on June 22, 1982, 64 days after the submission was received.
What is the product code of K821092?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.