TITAN GEL LDH ISOENZYME KIT
FDA 510(k) clearance K821983 · decided 1982-12-22
Clearance details
- K-number
- K821983
- Device name
- TITAN GEL LDH ISOENZYME KIT
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1982-07-06
- Decision date
- 1982-12-22
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- CEX
- Device class
- 2
- Regulation number
- 862.1445
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, 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 |
|---|---|---|
| LACTATE DEHYDROGENASE ISOENZYME 1 (K872891) | Data Medical Associates, Inc. | 1987-09-16 |
| LD-1(IMMUNO) SEPARATION SET (K851521) | Seragen Diagnostics, Inc. | 1985-05-10 |
| ISO-SEP SYSTEM (K842018) | Berwick Medical Products, Inc. | 1984-09-28 |
| ULTRACHEM T.P. (K821879) | Harleco Diagnostics | 1982-07-14 |
| CENTRIFICHEM CREATININE (K800129) | Union Carbide Corp. | 1980-02-13 |
| LDH ISOENZYME COLUMN REAGENT SET (K772356) | Worthington Biochemical Corp. | 1978-01-24 |
| LDH ISOENZYME CONTROL (K771894) | Bio-Reagents & Diagnostics, Inc. | 1977-12-22 |
Recalls involving this device
No recalls on record reference this clearance.