510(k) K953452
- Device
- KETOREX C SANWA
- Applicant
- IHARA MEDICS U.S., INC.
- 510(k) number
- K953452
- Product code
- JMK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-05-02
- Date received
- 1995-07-18
- Regulation
- 862.1380
- Classification name
- Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEONARD SPOLTER
- Address
- 25030 Ave. Tibbits, Unit K Valencia CA US 91355 91355
FDA Registration Numbers#
- 3004493545
- 1832216
- 3021841051
- 3003741796
- 3014325803
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JMK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983860 | MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 | Polymer Technology Systems, Inc. | 1999-12-27 |
| K981865 | MTM BIOSCANNER K TEST STRIPS | Polymer Technology Systems, Inc. | 1999-02-26 |
| K941427 | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) | Teco Diagnostics | 1995-03-13 |
| K862319 | HBDH (OPTIMIZED) REAGENT | Sigma Chemical Co. | 1986-07-07 |
| K843774 | RAICHEM X-HBDH REAGENT | Reagents Applications, Inc. | 1984-10-31 |
| K822739 | AHBD | Gilford Diagnostics | 1982-10-18 |
| K821877 | ULTRAZYME PLUS HBD | Harleco Diagnostics | 1982-07-14 |
| K781720 | HBDH ENZYME KINETIC REAGENT SET | Medical Analysis Systems, Inc. | 1978-11-03 |
| K780073 | HBDH REAGENT SET | Medical Analysis Systems, Inc. | 1978-02-13 |
| K780104 | ULTRAZYME PLUS HBD | Harleco | 1978-02-13 |
| K780042 | HYDORRYBUTYRATE DEHYDROGENASE | Beckman Instruments, Inc. | 1978-02-01 |
| K772033 | GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* | Harleco | 1977-11-17 |
| K771474 | MULTISTAT III X-HBDH TEST | Instrumentation Laboratory CO | 1977-09-13 |
| K770871 | ULTRAZYME PLUS HBD | Harleco | 1977-07-14 |
| K760023 | ULTRAZYME HBD | Harleco | 1976-08-26 |
Legacy Summary#
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FDA Review#
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