GELSCAN, MODEL 1206
FDA 510(k) clearance K100307 · decided 2010-08-31
Clearance details
- K-number
- K100307
- Device name
- GELSCAN, MODEL 1206
- Applicant
- Sebia
- Decision
- Substantially Equivalent
- Date received
- 2010-02-03
- Decision date
- 2010-08-31
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- CFE
- Device class
- 2
- Regulation number
- 862.1445
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPIFE LD-12 KIT, MODEL 3338 (K022455) | Helena Laboratories | 2002-10-01 |
| SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 (K020467) | Helena Laboratories | 2002-03-29 |
| HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT (K970477) | Sebia | 1997-03-10 |
| CARDIO REP LD (K940224) | Helena Laboratories | 1994-08-17 |
| ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD (K921455) | E.I. Dupont DE Nemours & Co., Inc. | 1992-04-29 |
| ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH (K905861) | E.I. Dupont DE Nemours & Co., Inc. | 1991-02-06 |
| ROCHO ISOMUNE - LD (K894081) | Roche Diagnostic Systems, Inc. | 1989-08-31 |
| REP(TM) LD-2 STAT KIT, CAT. NO. 3078 (K892818) | Helena Laboratories | 1989-06-20 |
| TITAN GEL REP LDH-30 HV (K874142) | Helena Laboratories | 1987-11-24 |
| TITAN GEL REP LDH-6 HV (K874145) | Helena Laboratories | 1987-11-24 |
| TITAN GEL REP LDH-12 HV (K874143) | Helena Laboratories | 1987-11-23 |
| TITAN GEL LDH REP SYSTEM (K873386) | Helena Laboratories | 1987-10-20 |
Recalls involving this device
No recalls on record reference this clearance.