510(k) K010670
- Device
- PICCOLO CHLORIDE TEST SYSTEM
- Applicant
- ABAXIS, INC.
- 510(k) number
- K010670
- Product code
- CHJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-04-26
- Date received
- 2001-03-06
- Regulation
- 862.1170
- Classification name
- Mercuric Thiocyanate, Colorimetry, Chloride
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- AMY LEVIN
- Address
- 3240 Whipple Rd. Union City CA US 94587 94587
FDA Registration Numbers#
- 3013660430
- 1832216
- 3006198300
- 2939693
- 1063851
- 1181121
- 2085064
- 1616487
- 3004192065
Source Documents#
Other 510(k) Records For Product Code CHJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945408 | 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER | Catachem, Inc. | 1995-02-22 |
| K943006 | CHLORIDE QVET | Prisma Systems | 1994-12-07 |
| K934136 | OLYMPUS CHLORIDE REAGENT, MODIFICATION | Olympus Corp. | 1993-11-05 |
| K932528 | OLYMPUS CHLORID REAGENT, MODIFIED | Olympus Corp. | 1993-09-17 |
| K925338 | OLYMPUS CHLORIDE REAGENT | Olympus Corp. | 1992-12-11 |
| K922921 | KING DIAGNOSTICS CHLORIDE REAGENT | King Diagnostics, Inc. | 1992-10-05 |
| K923610 | OLYMPUS CHLORIDE REAGENT | Olympus Corp. | 1992-10-02 |
| K923036 | URINE CHLORIDE | Heraeus Kulzer, Inc. | 1992-09-09 |
| K911297 | CHLORIDE REAGENT | Intersect Systems, Inc. | 1991-04-16 |
| K910133 | CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED | Olympus Corp. | 1991-02-27 |
| K901500 | CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA. | Olympus Corp. | 1990-07-10 |
| K892929 | TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES | Technicon Instruments Corp. | 1989-07-20 |
| K890015 | BIOTROL CHLORIDE | Biotrol, USA, Inc. | 1989-02-17 |
| K884601 | TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE | Technicon Instruments Corp. | 1989-01-27 |
| K884706 | CHLORIDE TEST (CL) ITEM #65659 | Em Diagnostic Systems, Inc. | 1989-01-11 |
Legacy Summary#
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FDA Review#
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