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510(k) K930757

RHEUMELISA II JO-1 ANTIBODY TEST KIT by Biowhittaker Molecular Applications, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1993
Date Received
February 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Biowhittaker Molecular Applications, Inc.

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  • K942245 — BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE (April 3, 1995)
  • K925209 — MUMPS STAT (October 14, 1994)
  • K935618 — SPECIMEN TRANSPORT MEDIUM (April 21, 1994)
  • K932679 — RHEUMELISA II HISTONE ANTIBODY TEST KIT (August 23, 1993)
  • K930130 — RHEUMELISA II SCL-70 ANTIBODY TEST KIT (March 23, 1993)
  • K920753 — RF STAT IGM TEST KIT (March 30, 1992)

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