Amylase Reagent Set (Modified Caraway)
FDA 510(k) K860530 · Sterling Diagnostics, Inc.
510(k) numberK860530
Submission
- Device name
- Amylase Reagent Set (Modified Caraway)
- Applicant
- Sterling Diagnostics, Inc.
Sterling Heights, MI, US - Received
- February 12, 1986
- Decision date
- February 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CJA – Amyloclastic, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K895555 | Modified Hi Chem Amylase Reagent (Product #88129)CJA · Traditional | Hichem Diagnostics | 12/22/1989SE |
| K884226 | Amylase Reagent Kit for Astra SystemsCJA · Traditional | A-Kem, Inc. | 12/09/1988SE |
| K883059 | Wako(Tm) Autokit AmylaseCJA · Traditional | Wako Chemicals USA, Inc. | 08/30/1988SE |
| K873520 | Paramax Amylase ReagentCJA · Traditional | Baxter Healthcare Corp | 11/23/1987SE |
| K863052 | Alpha AmylaseCJA · Traditional | J. D. Assoc. | 09/09/1986SE |
| K862640 | Amylase LTSCJA · Traditional | Electro-Nucleonics Laboratories, Inc. | 09/09/1986SE |
| K844168 | Amylase Reagent CS-726CJA · Traditional | Fisher Scientific Co., LLC | 11/20/1984SE |
| K843529 | Astra Systems Amylase Reagent KitCJA · Traditional | Beckman Instruments, Inc. | 10/11/1984SE |
| K833864 | Amylase Reagent Set-Modified CarawayCJA · Traditional | Sterling Biochemical, Inc. | 01/13/1984SE |
More from Sterling Biochemical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921412 | Microprotein Reagent SetCEK · Traditional | 01/21/1993SE |
| K914609 | Triglycerides Reagent SetCDT · Traditional | 11/07/1991SE |
| K914039 | Sodium Reagent SetCEI · Traditional | 10/31/1991SE |
| K914040 | Phospholipid Reagent SetJNT · Traditional | 10/30/1991SE |
| K862255 | Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional | 07/29/1986SE |
| K861962 | Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional | 07/07/1986SE |
| K862256 | Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional | 07/01/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | 07/01/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | 06/25/1986SE |
| K861855 | Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional | 06/16/1986SE |
Questions and answers
When was Amylase Reagent Set (Modified Caraway) cleared by the FDA?
Amylase Reagent Set (Modified Caraway) (K860530) received a 510(k) decision of Substantially Equivalent on February 28, 1986, 16 days after the submission was received.
What is the product code of K860530?
The FDA product code is CJA – Amyloclastic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.