PICCOLO METLYTE 7 REAGENT DISC
FDA 510(k) clearance K992140 · decided 1999-08-26
Clearance details
- K-number
- K992140
- Device name
- PICCOLO METLYTE 7 REAGENT DISC
- Applicant
- Abaxis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-24
- Decision date
- 1999-08-26
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JLB
- Device class
- 1
- Regulation number
- 862.1210
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sunnyvale, CA, 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 |
|---|---|---|
| OLYMPUS CK-MB REAGENT (K971817) | Olympus America, Inc. | 1997-06-11 |
| UNITEST CREATINE KINASE (K782156) | Boehringer Mannheim Corp. | 1979-03-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA recall (Z-2286-2008) | Abaxis Inc | 2008-09-17 |
| Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, mod recall (Z-2287-2008) | Abaxis Inc | 2008-09-17 |