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510(k) K900646

MERCURY THERMOMETERS (ORAL AND RECTAL) by Abel Industries, Inc. — Product Code FLK

K900646 is an FDA 510(k) premarket notification submitted by Abel Industries, Inc. for the device "MERCURY THERMOMETERS (ORAL AND RECTAL)". The FDA issued a decision of Substantially Equivalent on July 11, 1990. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1990
Date Received
February 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thermometer, Clinical Mercury
Device Class
Class II
Regulation Number
880.2920
Review Panel
HO
Submission Type

Other clearances for product code FLK

  • K960185 — AMSINO CLINICAL THERMOMETER (March 28, 1996)
  • K960224 — GERATHERM MERCUIRY FREE CLINICAL THERMOMETER (March 25, 1996)
  • K953465 — KENTEMP (December 15, 1995)
  • K942483 — CLINICAL GLASS THERMOMETER (March 28, 1995)
  • K941673 — MEDIAID UNIVERSAL THERMOMETER (August 25, 1994)
  • K940394 — AMG MED BRAND CLINICAL GLASS THERMOMETER (May 4, 1994)
  • K940380 — AMG MED BRAND CLINICAL GLASS THERMOMETER (May 4, 1994)
  • K932991 — GUARDIAN AND ANDINO MODELS (January 28, 1994)
  • K923225 — LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME (June 8, 1993)
  • K913793 — SIMPEX INC. ORAL AND RECTAL THERMOMETERS (December 30, 1991)

FDA data resources