FDA Product Code
FDA Product Code CEF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1630
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130500 | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT | Sebia | 2013-07-26 | Traditional | PDF ↗ |
| K972274 | SPIFE | Helena Laboratories | 1997-10-27 | Traditional | PDF ↗ |
| K973316 | REP SPE VIS-60/40 KIT | Helena Laboratories | 1997-10-01 | Traditional | PDF ↗ |
| K963018 | BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS | Bio-Rad | 1997-06-04 | Traditional | PDF ↗ |
| K964453 | REP 3 FLUR SPE-60 KIT | Helena Laboratories | 1996-12-23 | Traditional | PDF ↗ |
| K960029 | HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT | Morax | 1996-07-17 | Traditional | PDF ↗ |
| K951536 | HYDRAGEL PROTEIN(E) KIT | Sebia | 1995-06-30 | Traditional | PDF ↗ |
| K930317 | REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 | Helena Laboratories | 1993-08-03 | Traditional | PDF ↗ |
| K922053 | REP SPE PLUS (PONCEAU S) SYSTEM | Helena Laboratories | 1992-08-18 | Traditional | PDF ↗ |
| K922024 | REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 | Helena Laboratories | 1992-07-23 | Traditional | PDF ↗ |
| K913315 | BIO-RAD TOTAL PROTEIN TEST KIT | Bio-Rad | 1992-01-02 | Traditional | PDF ↗ |
| K913807 | REP(R) SPE TEMPLATE 30, 16, & 8 | Helena Laboratories | 1991-11-27 | Traditional | PDF ↗ |
| K913058 | REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 | Helena Laboratories | 1991-10-30 | Traditional | PDF ↗ |
| K912386 | REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 | Helena Laboratories | 1991-07-17 | Traditional | PDF ↗ |
| K911468 | REP SPE PLUS (ACID BLUE) SYSTEM | Helena Laboratories | 1991-04-16 | Traditional | PDF ↗ |
| K900251 | REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 | Helena Laboratories | 1990-02-26 | Traditional | PDF ↗ |
| K894585 | REP TM SPE (PONCEAU S) PROCEDURES | Helena Laboratories | 1989-09-13 | Traditional | PDF ↗ |
| K893211 | REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 | Helena Laboratories | 1989-06-19 | Traditional | PDF ↗ |
| K870958 | TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 | Helena Laboratories | 1987-04-29 | Traditional | PDF ↗ |
| K843397 | CORNING HIGH RESOLUTION PROTEIN ELECTRO | Corning Medical & Scientific | 1984-09-14 | Traditional | PDF ↗ |
| K833855 | TITAN GEL SILVER STAIN SYSTEM | Helena Laboratories | 1984-02-27 | Traditional | PDF ↗ |
| K811725 | TBG DIAGNOSTIC KIT | Immuno Assay Corp. | 1981-07-10 | Traditional | PDF ↗ |
| K802592 | PARAGON SERUM PROTEIN ELECTROPHORESIS | Beckman Instruments, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K781123 | PONCEAU S | Electrophoresis Corp. of America | 1978-08-10 | Traditional | PDF ↗ |
| K781116 | ECA BUFFER, PH 816 | Electrophoresis Corp. of America | 1978-08-10 | Traditional | PDF ↗ |
| K781118 | ECA BUFFER PH 8.8 | Electrophoresis Corp. of America | 1978-08-10 | Traditional | PDF ↗ |
| K781117 | ECA PREP | Electrophoresis Corp. of America | 1978-08-10 | Traditional | PDF ↗ |
| K781120 | TRICHLORACETIC ACID 7.5% | Electrophoresis Corp. of America | 1978-08-10 | Traditional | PDF ↗ |
| K771720 | AMIDO BLACK CONCENTRATE | Sigma Chemical Co. | 1977-11-03 | Traditional | PDF ↗ |
Product code CEF · Class I · Clinical Chemistry. Data: openFDA.