Home / 510(k) Clearances / K770231

510(k) K770231

MID-STREAM COLLECTION SET by Chesire Laboratories — Product Code FMH

K770231 is an FDA 510(k) premarket notification submitted by Chesire Laboratories for the device "MID-STREAM COLLECTION SET". The FDA issued a decision of Substantially Equivalent on March 30, 1977. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. Chesire Laboratories has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1977
Date Received
February 7, 1977
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 Chesire Laboratories

  • K924265 — DOCTOR'S CHOICE LATEX EXAMINATION GLOVES (March 15, 1993)
  • K924266 — DOCTOR'S CHOICE POWDER FREE LATEX EXAM GLOVES (February 10, 1993)
  • K770233 — STERILE SUCTION CATHETER W/CONTROL (April 5, 1977)

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)
  • K802340 — SPECIMEN SET (October 10, 1980)
  • 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)

FDA data resources