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510(k) K802340

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

K802340 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "SPECIMEN SET". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.

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

Other clearances by American Pharmaseal Div. Ahsc

  • K874022 — PHARMASEAL WOUND IRRIGATION DEVICE (December 30, 1987)
  • K874517 — PHARMASEAL RUBBER URETHRAL CATHETER (December 3, 1987)
  • K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER (December 3, 1987)
  • K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE (November 6, 1987)
  • K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM (September 4, 1987)
  • K872917 — JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER (August 11, 1987)
  • K871429 — ANTIMICROBIAL FOLEY CATHETER (August 10, 1987)
  • K871770 — AMERICAN PHARMASEAL WOUND DRESSING (June 26, 1987)
  • K870387 — EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE (May 8, 1987)
  • K870977 — PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE (April 1, 1987)

Other clearances for product code FMH

  • K900983 — TRI-TECH URINE SPECIMEN KIT (September 17, 1990)
  • K823763 — VARIOUS-SPECIMEN COLLECTORS (January 19, 1983)
  • K820180 — CALCULI FILTER CUP (February 5, 1982)
  • K812933 — LANCER SPECIMEN CONTAINER (November 6, 1981)
  • K802002 — URINE SPECIMEN CONTAINER #'S 1013-1016 (September 9, 1980)
  • K800947 — MIDSTREAM COLLECTION KIT (May 30, 1980)
  • K800309 — SPECIMEN COLLECTION PAN (February 26, 1980)
  • K800233 — ABCO MIDSTREAM URINE COLLECTION SET (February 26, 1980)
  • K792710 — PARA-PAK CLEAN VIAL (January 28, 1980)
  • K792156 — LANCER SPECIMEN CONTAINER (December 10, 1979)

FDA data resources