TBG Diagnostic Kit
FDA 510(k) K811725 · Immuno Assay Corp.
510(k) numberK811725
Submission
- Device name
- TBG Diagnostic Kit
- Applicant
- Immuno Assay Corp.
Mchenry, IL, US - Received
- June 18, 1981
- Decision date
- July 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEF – Electrophoretic, Protein Fractionation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1630
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130500 | Capillarys Immunotyping, Capillarys 2 Instrument, It/If Control, Capillarys 2 Flex…CEF · Traditional | Sebia | 07/26/2013SE |
| K972274 | SpifeCEF · Traditional | Helena Laboratories | 10/27/1997SE |
| K973316 | Rep Spe VIS-60/40 KitCEF · Traditional | Helena Laboratories | 10/01/1997SE |
| K963018 | Bio-Rad Serum Proteins by Capillary ElectrophoresisCEF · Traditional | Bio-Rad | 06/04/1997SE |
| K964453 | Rep 3 Flur SPE-60 KitCEF · Traditional | Helena Laboratories | 12/23/1996SE |
| K960029 | Hydrasys Agarose Gel Electrophoresis Apparatus/Hydragel 15,30 Protein KitCEF · Traditional | Morax | 07/17/1996SE |
| K951536 | Hydragel Protein(E) KitCEF · Traditional | Sebia | 06/30/1995SE |
| K930317 | Rep Spe Hi-Res Template System, Cat 3276/3277/3278CEF · Traditional | Helena Laboratories | 08/03/1993SE |
| K922053 | Rep Spe Plus (Ponceau S) SystemCEF · Traditional | Helena Laboratories | 08/18/1992SE |
| K922024 | Rep Spe Plus (Acid Blue) System,# 3173/3174/3175CEF · Traditional | Helena Laboratories | 07/23/1992SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K833842 | Ria Coat DigoxinDPO · Traditional | 01/17/1984SE |
| K833745 | Riacoat T-4CDX · Traditional | 01/04/1984SE |
| K820089 | TSH (Ria) KitJLW · Traditional | 01/28/1982SE |
| K820074 | Cortisol (Ria) KitCGR · Traditional | 01/28/1982SE |
| K811954 | Combo-Fer Iron DiagnosticJQG · Traditional | 07/27/1981SE |
| K811213 | T3 (Ria) KitCDP · Traditional | 05/29/1981SE |
| K811212 | Digoxin (Ria) KitDNL · Traditional | 05/21/1981SE |
| K810857 | T3 Uptake KitKHQ · Traditional | 04/08/1981SE |
| K810811 | T4 Ria KitCDX · Traditional | 04/07/1981SE |
Questions and answers
When was TBG Diagnostic Kit cleared by the FDA?
TBG Diagnostic Kit (K811725) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 22 days after the submission was received.
What is the product code of K811725?
The FDA product code is CEF – Electrophoretic, Protein Fractionation, a Class I (low risk) device regulated under 21 CFR 862.1630.