SPIFE
FDA 510(k) clearance K972274 · decided 1997-10-27
Clearance details
- K-number
- K972274
- Device name
- SPIFE
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1997-06-18
- Decision date
- 1997-10-27
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- CEF
- Device class
- 1
- Regulation number
- 862.1630
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 (K913058) | Helena Laboratories | 1991-10-30 |
Recalls involving this device
No recalls on record reference this clearance.