CEF — Electrophoretic, Protein Fractionation Class I
FDA product code CEF covers "Electrophoretic, Protein Fractionation", a Class I medical device regulated under 21 CFR 862.1630. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CEF
- Device Class
- Class I
- Regulation Number
- 862.1630
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K130500 | sebia | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FL | July 26, 2013 |
| K972274 | helena laboratories | SPIFE | October 27, 1997 |
| K973316 | helena laboratories | REP SPE VIS-60/40 KIT | October 1, 1997 |
| K963018 | bio-rad | BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS | June 4, 1997 |
| K964453 | helena laboratories | REP 3 FLUR SPE-60 KIT | December 23, 1996 |
| K960029 | morax | HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT | July 17, 1996 |
| K951536 | sebia | HYDRAGEL PROTEIN(E) KIT | June 30, 1995 |
| K930317 | helena laboratories | REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 | August 3, 1993 |
| K922053 | helena laboratories | REP SPE PLUS (PONCEAU S) SYSTEM | August 18, 1992 |
| K922024 | helena laboratories | REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 | July 23, 1992 |
| K913315 | bio-rad | BIO-RAD TOTAL PROTEIN TEST KIT | January 2, 1992 |
| K913807 | helena laboratories | REP(R) SPE TEMPLATE 30, 16, & 8 | November 27, 1991 |
| K913058 | helena laboratories | REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 | October 30, 1991 |
| K912386 | helena laboratories | REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 | July 17, 1991 |
| K911468 | helena laboratories | REP SPE PLUS (ACID BLUE) SYSTEM | April 16, 1991 |
| K900251 | helena laboratories | REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 | February 26, 1990 |
| K894585 | helena laboratories | REP TM SPE (PONCEAU S) PROCEDURES | September 13, 1989 |
| K893211 | helena laboratories | REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 | June 19, 1989 |
| K870958 | helena laboratories | TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 | April 29, 1987 |
| K843397 | corning medical and scientific | CORNING HIGH RESOLUTION PROTEIN ELECTRO | September 14, 1984 |