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510(k) K884612

FRANKLIN COLLECTOR(R) by Franklin Diagnostics, Inc. — Product Code FQZ

K884612 is an FDA 510(k) premarket notification submitted by Franklin Diagnostics, Inc. for the device "FRANKLIN COLLECTOR(R)". The FDA issued a decision of Substantially Equivalent on March 27, 1989. The device falls under product code FQZ (Thermometer, Clinical Color Change), a Class I device regulated under 21 CFR 880.2900. Franklin Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1989
Date Received
November 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thermometer, Clinical Color Change
Device Class
Class I
Regulation Number
880.2900
Review Panel
HO
Submission Type

Other clearances by Franklin Diagnostics, Inc.

  • K960195 — THYROCHEK ONE-STEP RAPID TSH ASSAY (April 15, 1996)

Other clearances for product code FQZ

  • K110305 — CRY-ACTRACKERCAM (January 13, 2012)
  • K963049 — STERI-AID KIT (November 12, 1996)
  • K946046 — DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP (July 19, 1995)
  • K894893 — POINT CHECKER COLOR STRIP THERMOMETER (April 5, 1990)
  • K881286 — TEMPA-DOT CLINICAL THERMOMETER SHEATH (June 8, 1988)
  • K863181 — HEALTHCHECK THERM-STRIP (September 11, 1986)
  • K853515 — PEE WEE THERMOMETERS (October 16, 1985)
  • K822423 — BABY TEMP PACIFIER (October 13, 1982)
  • K791574 — MODIFIED TEMPA-DOT THERMOMETER (September 12, 1979)
  • K790890 — TEMPO2-I DISPOSABLE THERMOMETERS (June 27, 1979)

FDA data resources