510(k) K821983
- Device
- Titan Gel Ldh Isoenzyme Kit
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K821983
- Product code
- CEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-22
- Date received
- 1982-07-06
- Regulation
- 862.1445
- Classification name
- Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3003741796
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872891 | LACTATE DEHYDROGENASE ISOENZYME 1 | Data Medical Associates, Inc. | 1987-09-16 |
| K851521 | LD-1(IMMUNO) SEPARATION SET | Seragen Diagnostics, Inc. | 1985-05-10 |
| K842018 | ISO-SEP SYSTEM | Berwick Medical Products, Inc. | 1984-09-28 |
| K821879 | ULTRACHEM T.P. | Harleco Diagnostics | 1982-07-14 |
| K800129 | CENTRIFICHEM CREATININE | Union Carbide Corp. | 1980-02-13 |
| K772356 | LDH ISOENZYME COLUMN REAGENT SET | Worthington Biochemical Corp. | 1978-01-24 |
| K771894 | LDH ISOENZYME CONTROL | Bio-Reagents & Diagnostics, Inc. | 1977-12-22 |