Amylase Reagent Set-Modified Caraway
FDA 510(k) K833864 · Sterling Biochemical, Inc.
510(k) numberK833864
Submission
- Device name
- Amylase Reagent Set-Modified Caraway
- Applicant
- Sterling Biochemical, Inc.
Mchenry, IL, US - Received
- November 7, 1983
- Decision date
- January 13, 1984
- 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 |
| 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 |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K844998 | Glucose(Hexokinase) Reagent SetCFR · Traditional | 01/18/1985SE |
| K844251 | Alt/Gpt Reagent SetCKA · Traditional | 01/08/1985SE |
| K843332 | Alkaline Phosphatase Reagent SetCJE · Traditional | 09/14/1984SE |
| K842521 | Ast/Got Reagent Set UV RateCIT · Traditional | 08/12/1984SE |
| K840064 | Urea Nitrogen Reagent SetCDQ · Traditional | 06/14/1984SE |
| K834084 | Hydroxybutyrate Dehydrogenase ReagentJKF · Traditional | 02/04/1984SE |
| K834045 | Uric Acid Reagent SetKNK · Traditional | 01/30/1984SE |
| K833062 | Serum Cholinesterase Reagent SetDLI · Traditional | 11/25/1983SE |
| K831874 | Lipase Reagent SetJGX · Traditional | 08/12/1983SE |
| K831415 | Lactic Dehydrogenase Reagent SetCFJ · Traditional | 06/16/1983SE |
Questions and answers
When was Amylase Reagent Set-Modified Caraway cleared by the FDA?
Amylase Reagent Set-Modified Caraway (K833864) received a 510(k) decision of Substantially Equivalent on January 13, 1984, 67 days after the submission was received.
What is the product code of K833864?
The FDA product code is CJA – Amyloclastic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.