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510(k) K820224

EMIT FREELEVEL SYSTEM I by Syva Co. — Product Code JRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1982
Date Received
January 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Filter, Membrane
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)

Other clearances for product code JRL

  • K822121 — ACRO PACK (August 5, 1982)
  • K820455 — CENTRIFREE MICROPARTITION SYSTEM (March 15, 1982)
  • K812750 — IL 703, STAT SEPARATOR (January 26, 1982)
  • K813159 — VACUSHIELD TM (December 8, 1981)
  • K810829 — ACRODISC (April 8, 1981)
  • K801500 — ULTRAFREE CALCIUM FILTER (August 20, 1980)
  • K790445 — ULTRA-FREE (June 28, 1979)
  • K781043 — CEA-IMMERSIBLE SEPARATOR (September 15, 1978)