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510(k) K831571

ROTOR by American Scientific Products — Product Code JJG

K831571 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "ROTOR". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140. American Scientific Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
May 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class
Class I
Regulation Number
862.2140
Review Panel
CH
Submission Type

Other clearances by American Scientific Products

  • K864824 — INFECTIOUS TISSUE KIT (December 24, 1986)
  • K844042 — BLOOD DILUTION VIAL (October 23, 1984)
  • K831634 — GLUCOSE REAGENT B6360-11 (July 19, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT (December 19, 1982)

Other clearances for product code JJG

  • K972409 — AG CHEMISTRY ANALYZER SYSTEM (August 28, 1997)
  • K942782 — PICCOLO(TM) (March 13, 1995)
  • K934592 — EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR (April 6, 1994)
  • K920942 — OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER (June 10, 1992)
  • K910222 — COBAS ALPHA (February 27, 1991)
  • K903626 — BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA (October 15, 1990)
  • K893854 — COBAS FARA II CENTRIFUGAL ANALYZER (August 3, 1989)
  • K893641 — COBAS FARA CENTRIFUGAL ANALYZER (July 20, 1989)
  • K885203 — TECHNICON DAX(TM) SYSTEM (March 28, 1989)
  • K871973 — IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (June 11, 1987)

FDA data resources