510(k) K851521
- Device
- LD-1(IMMUNO) SEPARATION SET
- Applicant
- SERAGEN DIAGNOSTICS, INC.
- 510(k) number
- K851521
- Product code
- CEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-10
- Date received
- 1985-04-15
- 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#
- Contact
- MICHAEL J SULLIVAN
- Address
- P.O. Box 1210 Indianapolis IN US 46206 46206
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 |
| K842018 | ISO-SEP SYSTEM | Berwick Medical Products, Inc. | 1984-09-28 |
| K821983 | TITAN GEL LDH ISOENZYME KIT | Helena Laboratories | 1982-12-22 |
| 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 |
Legacy Summary#
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FDA Review#
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