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510(k) K820180

CALCULI FILTER CUP by Omnimedical — Product Code FMH

K820180 is an FDA 510(k) premarket notification submitted by Omnimedical for the device "CALCULI FILTER CUP". The FDA issued a decision of Substantially Equivalent on February 5, 1982. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. Omnimedical has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1982
Date Received
January 22, 1982
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

Other clearances by Omnimedical

  • K837378 — OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM (May 18, 1983)
  • K812393 — 4001 CT SCANNER (October 13, 1981)
  • K812400 — OMNIMEDICAL QUAD I (October 2, 1981)
  • K802206 — OMNI SCANNER CT 6000 (October 23, 1980)
  • K790673 — OMNIMEDICAL AUTOMATIC 1001 (May 4, 1979)

Other clearances for product code FMH

  • K900983 — TRI-TECH URINE SPECIMEN KIT (September 17, 1990)
  • K823763 — VARIOUS-SPECIMEN COLLECTORS (January 19, 1983)
  • K812933 — LANCER SPECIMEN CONTAINER (November 6, 1981)
  • K802340 — SPECIMEN SET (October 10, 1980)
  • 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)

FDA data resources