Product code JMK
- Device name
- Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1380
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971674863397 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863403 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863410 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863427 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863434 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863441 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863458 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863465 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863472 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863489 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863496 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863502 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674863519 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 05055273215571 | LIQUID RANBUT (RBT) | RANDOX LABORATORIES LIMITED | 2022-09-23 |
| 05055273215588 | LIQUID RANBUT (RBT) | RANDOX LABORATORIES LIMITED | 2022-09-23 |
| 00381931718012 | PTS Panels® Ketones Test Strips | POLYMER TECHNOLOGY SYSTEMS, INC. | 2016-09-08 |