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510(k) K920753

RF STAT IGM TEST KIT by Biowhittaker Molecular Applications, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1992
Date Received
February 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

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  • K930130 — RHEUMELISA II SCL-70 ANTIBODY TEST KIT (March 23, 1993)

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