CORNING HIGH RESOLUTION PROTEIN ELECTRO
FDA 510(k) clearance K843397 · decided 1984-09-14
Clearance details
- K-number
- K843397
- Device name
- CORNING HIGH RESOLUTION PROTEIN ELECTRO
- Applicant
- Corning Medical & Scientific
- Decision
- Substantially Equivalent
- Date received
- 1984-08-29
- Decision date
- 1984-09-14
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- CEF
- Device class
- 1
- Regulation number
- 862.1630
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT (K130500) | Sebia | 2013-07-26 |
| SPIFE (K972274) | Helena Laboratories | 1997-10-27 |
| REP SPE VIS-60/40 KIT (K973316) | Helena Laboratories | 1997-10-01 |
| BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS (K963018) | Bio-Rad | 1997-06-04 |
| REP 3 FLUR SPE-60 KIT (K964453) | Helena Laboratories | 1996-12-23 |
| HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (K960029) | Morax | 1996-07-17 |
| HYDRAGEL PROTEIN(E) KIT (K951536) | Sebia | 1995-06-30 |
| REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 (K930317) | Helena Laboratories | 1993-08-03 |
| REP SPE PLUS (PONCEAU S) SYSTEM (K922053) | Helena Laboratories | 1992-08-18 |
| REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 (K922024) | Helena Laboratories | 1992-07-23 |
| BIO-RAD TOTAL PROTEIN TEST KIT (K913315) | Bio-Rad | 1992-01-02 |
| REP(R) SPE TEMPLATE 30, 16, & 8 (K913807) | Helena Laboratories | 1991-11-27 |
Recalls involving this device
No recalls on record reference this clearance.