JMK · Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Clinical Chemistry · 21 CFR 862.1380 · Class 1
Overview
| Product Code | JMK |
|---|---|
| Device Name | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase |
| Regulation | 21 CFR 862.1380 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Cleared Devices (16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K983860 | MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 | Polymer Technology Systems, Inc. | Dec 27, 1999 | SESE |
| K981865 | MTM BIOSCANNER K TEST STRIPS | Polymer Technology Systems, Inc. | Feb 26, 1999 | SESE |
| K953452 | KETOREX C SANWA | Ihara Medics U.S., Inc. | May 2, 1996 | SESE |
| K941427 | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) | Teco Diagnostics | Mar 13, 1995 | SESE |
| K862319 | HBDH (OPTIMIZED) REAGENT | Sigma Chemical Co. | Jul 7, 1986 | SESE |
| K843774 | RAICHEM X-HBDH REAGENT | Reagents Applications, Inc. | Oct 31, 1984 | SESE |
| K822739 | AHBD | Gilford Diagnostics | Oct 18, 1982 | SESE |
| K821877 | ULTRAZYME PLUS HBD | Harleco Diagnostics | Jul 14, 1982 | SESE |
| K781720 | HBDH ENZYME KINETIC REAGENT SET | Medical Analysis Systems, Inc. | Nov 3, 1978 | SESE |
| K780104 | ULTRAZYME PLUS HBD | Harleco | Feb 13, 1978 | SESE |
| K780073 | HBDH REAGENT SET | Medical Analysis Systems, Inc. | Feb 13, 1978 | SESE |
| K780042 | HYDORRYBUTYRATE DEHYDROGENASE | Beckman Instruments, Inc. | Feb 1, 1978 | SESE |
| K772033 | GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* | Harleco | Nov 17, 1977 | SESE |
| K771474 | MULTISTAT III X-HBDH TEST | Instrumentation Laboratory CO | Sep 13, 1977 | SESE |
| K770871 | ULTRAZYME PLUS HBD | Harleco | Jul 14, 1977 | SESE |
| K760023 | ULTRAZYME HBD | Harleco | Aug 26, 1976 | SESE |
Top Applicants
- Harleco — 4 clearances
- Polymer Technology Systems, Inc. — 2 clearances
- Medical Analysis Systems, Inc. — 2 clearances
- Teco Diagnostics — 1 clearance
- Sigma Chemical Co. — 1 clearance
