ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
FDA 510(k) clearance K131975 · decided 2013-10-02
Clearance details
- K-number
- K131975
- Device name
- ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-28
- Decision date
- 2013-10-02
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- CFJ
- Device class
- 2
- Regulation number
- 862.1440
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- West Caldwell, NJ, 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 |
|---|---|---|
| S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (K091544) | Alfa Wassermann, Inc. | 2009-09-09 |
| PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (K051108) | Abaxis, Inc. | 2005-07-08 |
| LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 (K974859) | Diagnostic Chemicals , Ltd. | 1998-01-22 |
| LIQUID LDH-L REAGENT SET (K973589) | Pointe Scientific, Inc., | 1997-10-08 |
| LACTATE DEHYDROGENASE (LD) (K970684) | Randox Laboratories, Ltd. | 1997-05-07 |
| LD-L REAGENT (K971398) | Carolina Liquid Chemistries Corp. | 1997-05-02 |
| LACTATE DEHYDROGENASE (K964912) | Derma Media Lab., Inc. | 1997-01-09 |
| LACTATE DEHYDROGENASE REAGENT SET (K961431) | Pointe Scientific, Inc., | 1996-06-03 |
| LACTATE DEHYDROGENASE REAGENT SYSTEM (K952747) | Medical Diagnostic Technologies, Inc. | 1995-08-07 |
| HICHEM LDH/L REAGENT KIT (K946022) | Hichem Diagnostics | 1995-02-23 |
| LACTATE DEHYDROGENASE QVET (K942964) | Prisma Systems | 1994-12-29 |
| LACTATE DEHYDROGENASE (LD) (K935175) | Em Diagnostic Systems, Inc. | 1993-12-16 |
Recalls involving this device
No recalls on record reference this clearance.