CLINISTAT LDH REAGENT TEST
FDA 510(k) clearance K895138 · decided 1989-10-19
Clearance details
- K-number
- K895138
- Device name
- CLINISTAT LDH REAGENT TEST
- Applicant
- Heraeus Kulzer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-16
- Decision date
- 1989-10-19
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- CFH
- Device class
- 2
- Regulation number
- 862.1440
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Elkhart, IN, 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 |
|---|---|---|
| SPOTCHEM II LDH TEST (K050790) | Arkray, Inc. | 2005-06-06 |
| CARESIDE LDH (K020484) | Careside, Inc. | 2002-07-03 |
| IQ LDH (K894578) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-17 |
| LACTATE DEHYDROGENASE (LDH-L) (K880630) | Tech-Co, Inc. | 1988-03-16 |
| LACTATE DEHYDROGENASE (LDH) REAGENT SET (K860349) | Sterling Diagnostics, Inc. | 1986-02-28 |
| EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (K852391) | Helena Laboratories | 1985-10-01 |
| WAKO LDH CII TEST (K842452) | Wako Chemicals USA, Inc. | 1984-08-15 |
| COLORIMETRIC LDH REAGENT SET (K820768) | Biorent Diagnostic, Inc. | 1982-04-14 |
| LDH REAGENT SET (K812836) | Anco Medical Reagents & Assoc. | 1981-10-09 |
| HYCEL LDH-INT TEST (K782176) | Hycel, Inc. | 1979-01-26 |
| LDH-INT TEST (K771343) | Hycel, Inc. | 1977-08-10 |
| COLORIMETRIC DETERMINATION (LDH) (K760009) | The Dow Chemical Co. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.