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510(k) K830705

MINI LANCET-BLOOD LANCET by Pharmaquest Corp. — Product Code FMA

K830705 is an FDA 510(k) premarket notification submitted by Pharmaquest Corp. for the device "MINI LANCET-BLOOD LANCET". The FDA issued a decision of Substantially Equivalent on April 8, 1983. The device falls under product code FMA (Depressor, Tongue, Non-Surgical), a Class I device regulated under 21 CFR 880.6230. Pharmaquest Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1983
Date Received
March 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Depressor, Tongue, Non-Surgical
Device Class
Class I
Regulation Number
880.6230
Review Panel
HO
Submission Type

Other clearances by Pharmaquest Corp.

  • K945519 — FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE AN (November 3, 1995)
  • K833880 — TELEPHONIC RECEIVER R-10 EEG (November 29, 1983)
  • K833236 — TELEPHONE TRANSMITTER T-10 EEG (November 29, 1983)
  • K822976 — HYPOCOUNT A (November 16, 1982)
  • K822486 — HOME BLOOD GLUCOSE MONITOR (November 5, 1982)
  • K820248 — RODDER VOLUME VENTILATOR (April 16, 1982)
  • K812849 — PTT-200 TELEPHONIC PULMONARY TRANSMITT (December 3, 1981)
  • K812850 — PTT-200 PULMONARY RECEIVER/MICROPROCES (December 3, 1981)
  • K813010 — EEG TELEPHONE TRANSMITTER, MODEL #T-7 (November 16, 1981)
  • K812683 — NEONATE FLEXFLOAT (October 13, 1981)

Other clearances for product code FMA

  • K992995 — AROMATIC AND FLAVORED TONGUE DEPRESSOR (December 9, 1999)
  • K842461 — TONGUE DEPRESSOR (November 30, 1984)
  • K821177 — BITE STICK (May 21, 1982)
  • K770120 — MOUTH WASH TRAY (January 28, 1977)

FDA data resources