510(k) K771474
- Device
- MULTISTAT III X-HBDH TEST
- Applicant
- Instrumentation Laboratory CO
- 510(k) number
- K771474
- Product code
- JMK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-13
- Date received
- 1977-08-04
- 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
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K953452 | KETOREX C SANWA | Ihara Medics U.S., Inc. | 1996-05-02 |
| 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 |
| K770871 | ULTRAZYME PLUS HBD | Harleco | 1977-07-14 |
| K760023 | ULTRAZYME HBD | Harleco | 1976-08-26 |