Rep Spe Plus (Acid Blue) System
FDA 510(k) K911468 · Helena Laboratories
510(k) numberK911468
Submission
- Device name
- Rep Spe Plus (Acid Blue) System
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- April 3, 1991
- Decision date
- April 16, 1991
- 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 |
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| K061069 | Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional | 07/06/2006SE |
| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
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Questions and answers
When was Rep Spe Plus (Acid Blue) System cleared by the FDA?
Rep Spe Plus (Acid Blue) System (K911468) received a 510(k) decision of Substantially Equivalent on April 16, 1991, 13 days after the submission was received.
What is the product code of K911468?
The FDA product code is CEF – Electrophoretic, Protein Fractionation, a Class I (low risk) device regulated under 21 CFR 862.1630.