510(k) K896170
- Device
- Rep Ck Isoforms Kit Cat. No. 3081, 3082, 3083
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K896170
- Product code
- JHT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-16
- Date received
- 1989-10-25
- Regulation
- 862.1215
- Classification name
- Chromatographic Separation, Cpk Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAT FRANKS
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 2029372
- 2246703
- 3010825766
- 2517506
- 3005174594
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JHT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022409 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | Spectral Diagnostics, Inc. | 2002-09-30 |
| K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI | Princeton BioMeditech Corp. | 1999-05-28 |
| K930359 | CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 | Helena Laboratories | 1993-04-12 |
| K904866 | COULTER CK-MB ISOENZYME REAGENT | Coulter Electronics, Inc. | 1990-12-13 |
| K904721 | DSL CK-MB (DSL #3200) | Diagnostic Systems Laboratories, Inc. | 1990-12-13 |
| K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | Intl. Immunoassay Laboratories, Inc. | 1990-05-15 |
| K881168 | CREATINE KINASE (CK) ISOENZYME MB | Data Medical Associates, Inc. | 1988-11-10 |
| K874284 | SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM | Diagnostic Chemicals, Ltd. (Usa) | 1988-01-21 |
| K872041 | COULTER DART CK-MB ISOENZYME REAGENT SYSTEM | Coulter Electronics, Inc. | 1987-09-16 |
| K872598 | MICROMI-CK(TM) | Intl. Immunoassay Laboratories, Inc. | 1987-08-03 |
| K872592 | IMACK-MB(TM) | Intl. Immunoassay Laboratories, Inc. | 1987-07-31 |
| K831391 | SHOT GUN KIT FOR CK-MB | Serapine Corp. | 1983-11-04 |
| K823550 | CK-ISOZYME U.V. REAGENT SET | Gelman Sciences, Inc. | 1983-01-07 |
| K822124 | TITAN GEL CPK ISOENZYME SYSTEM | Helena Laboratories | 1982-11-01 |
| K821964 | 125I QUICK-MB TEST KIT FOR QUANTITATION | Intl. Immunoassay Laboratories, Inc. | 1982-07-22 |