LACTEST I
FDA 510(k) clearance K971944 · decided 1997-12-17
Clearance details
- K-number
- K971944
- Device name
- LACTEST I
- Applicant
- Jwt, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-27
- Decision date
- 1997-12-17
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- KHP
- Device class
- 1
- Regulation number
- 862.1450
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bethlehem, PA, 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 |
|---|---|---|
| PICCOLO LACTATE TEST SYSTEM (K130113) | Abaxis, Inc. | 2013-03-11 |
| RAPIDPOINT 500 BLOOD GAS ANALYER (K113216) | Siemens Healthcare Diagnostics | 2012-05-03 |
| NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (K112955) | Nova Biomedical Corporation | 2012-01-05 |
| I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (K112430) | Abbott Pont of Care, Inc. | 2011-12-20 |
| NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (K100602) | Nova Biomedical Corp. | 2011-08-17 |
| EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (K093297) | Epocal, Inc. | 2010-06-09 |
| IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (K013938) | Diametrics Medical, Inc. | 2002-01-28 |
| I-STAT SYSTEM (K011478) | I-Stat Corp. | 2001-07-02 |
| LACTATE PRO SYSTEM (K980908) | Kdk Corp. | 1998-09-11 |
| I-STAT LACTATE TEST (K982071) | I-Stat Corp. | 1998-06-29 |
| ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR (K951331) | Boehringer Mannheim Corp. | 1995-08-11 |
| STAT PROFILE PLUS 9 ANALYZER (K936066) | Nova Biomedical Corp. | 1995-03-09 |
Recalls involving this device
No recalls on record reference this clearance.