510(k) K811575
- Device
- CARDIOZYME PLUS CK-MB ITEM #65045 (G)
- Applicant
- HARLECO
- 510(k) number
- K811575
- Product code
- JHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-06-25
- Date received
- 1981-06-04
- Regulation
- 862.1215
- Classification name
- U.v. Method, Cpk Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8040374
- 1616487
- 1827821
- 2050010
- 3007662974
- 2050012
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JHW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162526 | Creatine Kinase-MB | Roche Diagnostics | 2017-05-26 |
| K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | Elitechgroup | 2014-07-18 |
| K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL | Elitechgroup | 2012-08-22 |
| K023744 | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 | Wiener Laboratories Saic | 2003-01-03 |
| K003158 | ROCHE DIAGNOSTICS CK-MB | Roche Diagnostics Corp. | 2000-12-18 |
| K961501 | ELECSYS CK-MB | Boehringer Mannheim Corp. | 1996-06-11 |
| K950186 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Miles, Inc. | 1995-03-13 |
| K944325 | LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN | Princeton BioMeditech Corp. | 1995-02-22 |
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | Biochemical Trade, Inc. | 1994-11-21 |
| K935924 | AXSYM CK-MB | Abbott Laboratories | 1994-06-21 |
| K931050 | CARDIO REP CK ISOENZYME KIT - 3310 | Helena Laboratories | 1993-04-20 |
| K913349 | STAMBI-CK | Intl. Immunoassay Laboratories, Inc. | 1991-10-23 |
| K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1991-07-08 |
| K905588 | CREATINE KINASE UV REAGENT SET | Biochemical Trade, Inc. | 1991-01-17 |
| K903508 | LABELLING CHANGES TO IMPRES-MB-X | Intl. Immunoassay Laboratories, Inc. | 1990-09-07 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases