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510(k) K801258

NEEDLE COUNTER-SURE COUNT/10 COUNT by Kleen Test Products — Product Code BXX

K801258 is an FDA 510(k) premarket notification submitted by Kleen Test Products for the device "NEEDLE COUNTER-SURE COUNT/10 COUNT". The FDA issued a decision of Substantially Equivalent on June 4, 1980. The device falls under product code BXX (Calibrator, Pressure, Gas), a Class I device regulated under 21 CFR 868.2620. Kleen Test Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1980
Date Received
May 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Pressure, Gas
Device Class
Class I
Regulation Number
868.2620
Review Panel
AN
Submission Type

Other clearances by Kleen Test Products

  • K890039 — KLEEN TEST BASIN SET (October 24, 1989)
  • K890539 — SURE COUNT LIGHT HANDLE COVER (February 27, 1989)
  • K890098 — KLEEN TEST O.R. KIT (January 24, 1989)
  • K853622 — SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 (October 10, 1985)
  • K853454 — SURE COUNT 5 & 10 SPONGE COUNTER (September 5, 1985)
  • K853315 — CAUTERY TIP CLEANING PAD (August 21, 1985)
  • K852258 — SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER (June 27, 1985)
  • K852257 — SURE-COUNT 15 COUNT NEEDLE COUNTER (June 26, 1985)
  • K844199 — ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET (November 7, 1984)
  • K821396 — OUT-RITE WASTE DISPOSABLE BAG (June 9, 1982)

Other clearances for product code BXX

  • K923397 — SINGLE DOSE GAS INJECTOR (September 14, 1992)
  • K875075 — RT-200 COMPUTER INTERFACE (April 21, 1988)
  • K850029 — UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL (April 29, 1985)
  • K822746 — RT-200 CALIBRATION ANALYZER (October 13, 1982)
  • K801257 — NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. (June 4, 1980)
  • K801256 — NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY (June 4, 1980)
  • K791294 — SPIROCAL (August 16, 1979)
  • K780981 — PORTABLE PNEUMATIC CALIBRATOR 65-150 (August 2, 1978)
  • K780838 — PERCI (July 17, 1978)

FDA data resources