Question 1

Who is the manufacturer of SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500?

Accepted Answer

Dade Behring, Inc. submitted the Traditional clearance for SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K000649).

Question 2

What is the FDA product code for SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500?

Accepted Answer

GGP. It is classified under 21 CFR 864.7290 as a Class 2 device in the Hematology panel.

Question 3

When was SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 cleared by the FDA?

Accepted Answer

Apr 25, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500?

Accepted Answer

510(k) clearance (submission type: Traditional).

Record ID	K000649
Device Name	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
Applicant	Dade Behring, Inc.
Product Code	GGP · Hematology
Decision Date	Apr 25, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.7290
Device Class	Class 2

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

Device Facts