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510(k) K842018

ISO-SEP SYSTEM by Berwick Medical Products, Inc. — Product Code CEX

K842018 is an FDA 510(k) premarket notification submitted by Berwick Medical Products, Inc. for the device "ISO-SEP SYSTEM". The FDA issued a decision of Substantially Equivalent on September 28, 1984. The device falls under product code CEX (Chromatographic Separation, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Berwick Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1984
Date Received
May 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
Review Panel
CH
Submission Type

Other clearances by Berwick Medical Products, Inc.

  • K850800 — DROPSTIRS - PLASTIC DISPOSABLE PIPET (April 2, 1985)
  • K831434 — ISO-SEP SYSTEM (June 30, 1983)
  • K831289 — PREFILLED IEC COLUMNS (June 16, 1983)
  • K830918 — I.E.C COLUMN (April 27, 1983)

Other clearances for product code CEX

  • K872891 — LACTATE DEHYDROGENASE ISOENZYME 1 (September 16, 1987)
  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K821983 — TITAN GEL LDH ISOENZYME KIT (December 22, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K800129 — CENTRIFICHEM CREATININE (February 13, 1980)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K771894 — LDH ISOENZYME CONTROL (December 22, 1977)

FDA data resources