Product code CJA— Clinical Chemistry

FDA has cleared 10 devices under product code CJA between 1984 and 1989, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19891 clearance
• 19882 clearances
• 19871 clearance
• 19863 clearances
• 19843 clearances

• Wako Chemicals USA, Inc.1 clearance
• Sterling Diagnostics, Inc.1 clearance
• Sterling Biochemical, Inc.1 clearance
• J. D. Assoc.1 clearance
• Hichem Diagnostics1 clearance
• Fisher Scientific Co., LLC1 clearance
• Electro-Nucleonics Laboratories, Inc.1 clearance
• Beckman Instruments, Inc.1 clearance
• Baxter Healthcare Corp1 clearance
• A-Kem, Inc.1 clearance

• K895555 — MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)Hichem Diagnostics·1989-12-22
• K884226 — AMYLASE REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.·1988-12-09
• K883059 — WAKO(TM) AUTOKIT AMYLASEWako Chemicals USA, Inc.·1988-08-30
• K873520 — PARAMAX AMYLASE REAGENTBaxter Healthcare Corp·1987-11-23
• K862640 — AMYLASE LTSElectro-Nucleonics Laboratories, Inc.·1986-09-09
• K863052 — ALPHA AMYLASEJ. D. Assoc.·1986-09-09
• K860530 — AMYLASE REAGENT SET (MODIFIED CARAWAY)Sterling Diagnostics, Inc.·1986-02-28
• K844168 — AMYLASE REAGENT CS-726Fisher Scientific Co., LLC·1984-11-20
• K843529 — ASTRA SYSTEMS AMYLASE REAGENT KITBeckman Instruments, Inc.·1984-10-11
• K833864 — AMYLASE REAGENT SET-MODIFIED CARAWAYSterling Biochemical, Inc.·1984-01-13