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510(k) K852306

REPLACEMENT REAGENTS FOR SMAC II SYSTEMS by Methodist Hospital of Memphis — Product Code JJC

K852306 is an FDA 510(k) premarket notification submitted by Methodist Hospital of Memphis for the device "REPLACEMENT REAGENTS FOR SMAC II SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 2, 1985. The device falls under product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use), a Class I device regulated under 21 CFR 862.2150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1985
Date Received
May 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device Class
Class I
Regulation Number
862.2150
Review Panel
CH
Submission Type

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  • K901141 — PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX (April 9, 1990)
  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
  • K881056 — AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 (November 15, 1988)
  • K875105 — TECHNICON SMAC 3 SYSTEM (February 16, 1988)
  • K870998 — TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (May 26, 1987)
  • K862561 — TECHNICON RA-XT SYSTEM WITH ANALYTES (October 20, 1986)

FDA data resources