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510(k) K810856

DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT by Bartels Immunodiagnostic Supplies, Inc. — Product Code GPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1981
Date Received
March 30, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Psittacosis (Chlamydia Group)
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

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  • K842833 — PMK PRIMARY MONKEY KIDNEY-CELLS (August 28, 1984)
  • K842834 — HEP-2 CELLS (August 28, 1984)
  • K842328 — AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN (August 3, 1984)