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510(k) K802340

SPECIMEN SET by American Pharmaseal Div. Ahsc — Product Code FMH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
HO
Submission Type

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Other clearances for product code FMH

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  • K812933 — LANCER SPECIMEN CONTAINER (November 6, 1981)
  • K802002 — URINE SPECIMEN CONTAINER #'S 1013-1016 (September 9, 1980)
  • K800947 — MIDSTREAM COLLECTION KIT (May 30, 1980)
  • K800233 — ABCO MIDSTREAM URINE COLLECTION SET (February 26, 1980)
  • K800309 — SPECIMEN COLLECTION PAN (February 26, 1980)
  • K792710 — PARA-PAK CLEAN VIAL (January 28, 1980)
  • K792156 — LANCER SPECIMEN CONTAINER (December 10, 1979)