Amylase LTS
FDA 510(k) K862640 · Electro-Nucleonics Laboratories, Inc.
510(k) numberK862640
Submission
- Device name
- Amylase LTS
- Applicant
- Electro-Nucleonics Laboratories, Inc.
Columbia, MD, US - Received
- July 10, 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 |
| K863052 | Alpha AmylaseCJA · Traditional | J. D. Assoc. | 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 |
|---|---|---|
| K873925 | Virgo(Tm) Measles Igg ElisaLJB · Traditional | 02/24/1988SE |
| K873617 | Gemstar II SystemJJE · Traditional | 10/19/1987SE |
| K873416 | Multi-Access Reagent DispenserJQW · Traditional | 10/09/1987SE |
| K873358 | Gemeni Uric Acid U.V.CDO · Traditional | 09/11/1987SE |
| K873088 | Virgo(Tm) Rubella Igg ElisaLFX · Traditional | 09/09/1987SE |
| K871905 | Toxoplasma Gondii Igg ElisaLGD · Traditional | 07/30/1987SE |
| K870928 | Cholesterol (Total) Analysis ProductsCHH · Traditional | 04/22/1987SE |
| K863874 | Lipase Hydrolysis/Glycerol Kinase, TriglyceridesCDT · Traditional | 11/13/1986SE |
| K853372 | Gemstar Ipa Theophylline Test KitKLS · Traditional | 09/04/1985SE |
| K853373 | Delta Trol I & IIJJT · Traditional | 08/23/1985SE |
Questions and answers
When was Amylase LTS cleared by the FDA?
Amylase LTS (K862640) received a 510(k) decision of Substantially Equivalent on September 9, 1986, 61 days after the submission was received.
What is the product code of K862640?
The FDA product code is CJA – Amyloclastic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.