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510(k) K844948

SYVA SOLID PHASE COLUMNS by Syva Co. — Product Code KEA

K844948 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "SYVA SOLID PHASE COLUMNS". The FDA issued a decision of Substantially Equivalent on August 29, 1985. The device falls under product code KEA (Resins, Ion-Exchange), a Class I device regulated under 21 CFR 862.2230. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1985
Date Received
December 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resins, Ion-Exchange
Device Class
Class I
Regulation Number
862.2230
Review Panel
TX
Submission Type

Other clearances by Syva Co.

  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 2001)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)
  • K993982 — SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL (January 27, 2000)

Other clearances for product code KEA

  • K890997 — ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) (March 28, 1989)
  • K842028 — CM-TRISACRYL M DEAE-TRISACRYL M (June 7, 1984)
  • K833320 — AMBERLITE CG50 RESIN, 100-200 MESH (December 8, 1983)
  • K833319 — BIO-REX 70 RESIN 100-200 MESH PH6.2 (November 3, 1983)
  • K831027 — EXTRELUT QE EXTRACTION COLUMNS (May 16, 1983)
  • K830918 — I.E.C COLUMN (April 27, 1983)
  • K782066 — EXETRELUT (January 3, 1979)
  • K781728 — EXTUBE (December 20, 1978)

FDA data resources