Alpha Amylase
FDA 510(k) K863052 · J. D. Assoc.
510(k) numberK863052
Submission
- Device name
- Alpha Amylase
- Applicant
- J. D. Assoc.
Montclair, NJ, US - Received
- August 12, 1986
- Decision date
- September 9, 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 |
| K862640 | Amylase LTSCJA · Traditional | Electro-Nucleonics Laboratories, Inc. | 09/09/1986SE |
| K860530 | Amylase Reagent Set (Modified Caraway)CJA · Traditional | Sterling Diagnostics, Inc. | 02/28/1986SE |
| 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 |
|---|---|---|
| K863103 | Peg 6,000CHH · Traditional | 01/13/1987SE |
| K863054 | Ast S.C.E. (Got)CIT · Traditional | 01/13/1987SE |
| K863069 | MagnesiometerJGJ · Traditional | 12/31/1986SE |
| K863079 | CreatinkineticCGX · Traditional | 12/12/1986SE |
| K863112 | ProteinmeterJGP · Traditional | 12/10/1986SE |
| K863068 | LDH S.C.E.CFJ · Traditional | 12/10/1986SE |
| K863053 | Alt S.C.E. (GPT)CKA · Traditional | 12/10/1986SE |
| K863066 | TransfermeterJQF · Traditional | 12/04/1986SE |
| K863109 | FerrofastJIY · Traditional | 11/24/1986SE |
| K863102 | Glucometer-ECGA · Traditional | 11/24/1986SE |
Questions and answers
When was Alpha Amylase cleared by the FDA?
Alpha Amylase (K863052) received a 510(k) decision of Substantially Equivalent on September 9, 1986, 28 days after the submission was received.
What is the product code of K863052?
The FDA product code is CJA – Amyloclastic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.