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510(k) K881056

AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 by American Research Products Co. — Product Code JJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1988
Date Received
March 11, 1988
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

Other clearances by American Research Products Co.

  • K942984 — BUN REAGENT (March 1, 1995)
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  • K901960 — IRON REAGENTS PRODUCT CODES 7725 AND 7726 (May 31, 1990)
  • K901964 — PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 (May 31, 1990)
  • K900827 — COLORIMETRIC CHLORIDE PRODUCT #4314125 (May 2, 1990)
  • K901702 — NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 (April 25, 1990)
  • K900667 — AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 (April 19, 1990)
  • K900666 — AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 (April 19, 1990)
  • K900571 — AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) (April 16, 1990)
  • K900394 — AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 (April 11, 1990)

Other clearances for product code JJC

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  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)
  • K901141 — PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX (April 9, 1990)
  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
  • 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)
  • K854345 — TECHNICON RA-500 SYSTEM (November 26, 1985)