Modified Hi Chem Amylase Reagent (Product #88129)
FDA 510(k) K895555 · Hichem Diagnostics
510(k) numberK895555
Submission
- Device name
- Modified Hi Chem Amylase Reagent (Product #88129)
- Applicant
- Hichem Diagnostics
Brea, CA, US - Received
- September 6, 1989
- Decision date
- December 22, 1989
- 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 |
|---|---|---|---|
| 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 |
| K833864 | Amylase Reagent Set-Modified CarawayCJA · Traditional | Sterling Biochemical, Inc. | 01/13/1984SE |
More from Sterling Biochemical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981794 | Hichem Calcium Reagent KitCJY · Traditional | 07/29/1998SE |
| K963383 | Hichem Alp/Amp Reagent KitCKF · Traditional | 09/23/1996SE |
| K953863 | Hichem Ise Standards Kit 70011JIX · Traditional | 09/06/1995SE |
| K953862 | Hichem Isekci Solution Kit 70010CGZ · Traditional | 09/06/1995SE |
| K953861 | Hichem Ise Intdernal Reference Kit 70009CGZ · Traditional | 09/06/1995SE |
| K953860 | Hichem Ise Diluent Kit 70008CGZ · Traditional | 09/06/1995SE |
| K951751 | Hichem Ast Reagent KitCIT · Traditional | 08/02/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | 05/02/1995SE |
| K946022 | Hichem Ldh/L Reagent KitCFJ · Traditional | 02/23/1995SE |
| K941433 | Hi Chem Aqueous Glucose Control, Low, Med, HighJJX · Traditional | 08/02/1994SE |
Questions and answers
When was Modified Hi Chem Amylase Reagent (Product #88129) cleared by the FDA?
Modified Hi Chem Amylase Reagent (Product #88129) (K895555) received a 510(k) decision of Substantially Equivalent on December 22, 1989, 107 days after the submission was received.
What is the product code of K895555?
The FDA product code is CJA – Amyloclastic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.