Amylase Reagent CS-726
FDA 510(k) K844168 · Fisher Scientific Co., LLC
510(k) numberK844168
Submission
- Device name
- Amylase Reagent CS-726
- Applicant
- Fisher Scientific Co., LLC
Fair Lawn, NJ, US - Received
- October 25, 1984
- Decision date
- November 20, 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 |
| 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 |
|---|---|---|
| K930415 | Microhematocrit RotorGKG · Traditional | 03/23/1993SE |
| K915825 | Marathon 6K General-Purpose CentrifugeGKF · Traditional | 03/11/1992SE |
| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | 01/08/1992SE |
| K890534 | Modified Uriqual(Tm) Urinalysis Control Level 1JJW · Traditional | 03/08/1989SE |
| K881275 | Uriqual(Tm) Urinalysis Controls (Human) I & IIJJY · Traditional | 05/16/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
| K871058 | Serachem Liquid Spinal Fluid Control (Human)JJY · Traditional | 04/06/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | 07/10/1986SE |
Questions and answers
When was Amylase Reagent CS-726 cleared by the FDA?
Amylase Reagent CS-726 (K844168) received a 510(k) decision of Substantially Equivalent on November 20, 1984, 26 days after the submission was received.
What is the product code of K844168?
The FDA product code is CJA – Amyloclastic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.