Ultrazyme HBD
FDA 510(k) K760023 · Harleco
510(k) numberK760023
Submission
- Device name
- Ultrazyme HBD
- Applicant
- Harleco
Mchenry, IL, US - Received
- June 14, 1976
- Decision date
- August 26, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMK – Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1380
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983860 | MTM Bioscanner K Test Strips, Cat # BSA610JMK · Traditional | Polymer Technology Systems, Inc. | 12/27/1999SE |
| K981865 | MTM Bioscanner K Test StripsJMK · Traditional | Polymer Technology Systems, Inc. | 02/26/1999SE |
| K953452 | Ketorex C SanwaJMK · Traditional | Ihara Medics U.S., Inc. | 05/02/1996SE |
| K941427 | Serum @-Hydroxybutyrate Dehydrogenase (HBDH)JMK · Traditional | Teco Diagnostics | 03/13/1995SE |
| K862319 | HBDH (Optimized) ReagentJMK · Traditional | Sigma Chemical Co. | 07/07/1986SE |
| K843774 | Raichem X-Hbdh ReagentJMK · Traditional | Reagents Applications, Inc. | 10/31/1984SE |
| K822739 | AhbdJMK · Traditional | Gilford Diagnostics | 10/18/1982SE |
| K821877 | Ultrazyme Plus HBDJMK · Traditional | Harleco Diagnostics | 07/14/1982SE |
| K781720 | HBDH Enzyme Kinetic Reagent SetJMK · Traditional | Medical Analysis Systems, Inc. | 11/03/1978SE |
| K780104 | Ultrazyme Plus HBDJMK · Traditional | Harleco | 02/13/1978SE |
More from Harleco
| 510(k) | Device | Decision |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Ultrazyme HBD cleared by the FDA?
Ultrazyme HBD (K760023) received a 510(k) decision of Substantially Equivalent on August 26, 1976, 73 days after the submission was received.
What is the product code of K760023?
The FDA product code is JMK – Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase, a Class I (low risk) device regulated under 21 CFR 862.1380.