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510(k) K771591

MINISTAT-S CHEMISTRY ANALYZER by Biokinetix Corp. — Product Code JJI

K771591 is an FDA 510(k) premarket notification submitted by Biokinetix Corp. for the device "MINISTAT-S CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on September 20, 1977. The device falls under product code JJI (Analyzer, Enzyme, For Clinical Use), a Class I device regulated under 21 CFR 862.2500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1977
Date Received
August 19, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Enzyme, For Clinical Use
Device Class
Class I
Regulation Number
862.2500
Review Panel
CH
Submission Type

Other clearances for product code JJI

  • K972024 — CODA AUTOMATED EIA ANALYZER (July 30, 1997)
  • K944731 — ABBOTT IMX 2 ANALYZER (December 19, 1994)
  • K931970 — ABBOTT IMX2 ANALYER (June 16, 1993)
  • K930898 — RADIAS AUTOMATED IMMUNOASSAY SYSTEM (April 21, 1993)
  • K790073 — ANALYZER, IMPACT 100 (February 22, 1979)
  • K780972 — QUICKRATE REACTION RATE ANALYZER (August 14, 1978)
  • K770401 — LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE (April 26, 1977)

FDA data resources