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510(k) K812601

SQC BUFFER by Transidyne General Corp. — Product Code JJS

K812601 is an FDA 510(k) premarket notification submitted by Transidyne General Corp. for the device "SQC BUFFER". The FDA issued a decision of Substantially Equivalent on October 2, 1981. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Transidyne General Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1981
Date Received
September 14, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controls For Blood-Gases, (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Transidyne General Corp.

  • K961217 — BODILY FLUID DISPOSAL KIT (July 25, 1996)
  • K955658 — LACERATION TRAY (January 25, 1996)
  • K950773 — PROPHYLAXIS PACK (March 31, 1995)
  • K950743 — ORAL PROCEDURE PACK (March 31, 1995)
  • K950449 — SURGICAL BUR (March 1, 1995)
  • K950403 — SURGICAL SAW BLADES (February 21, 1995)
  • K924811 — I.V. START KIT (June 17, 1993)
  • K924243 — TRACHEOSTOMY CARE KIT (June 16, 1993)
  • K922339 — SUTURE REMOVAL KIT (December 11, 1992)
  • K922041 — PRIMARY SURGICAL DRESSING TRAY (November 6, 1992)

Other clearances for product code JJS

  • K152553 — CueSee Hypoxic (April 22, 2016)
  • K150226 — Hematocrit and Metabolite QUALICHECK (May 13, 2015)
  • K130415 — HIGH METABOLITE QUALICHECK (March 26, 2013)
  • K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL (March 15, 2013)
  • K033063 — MISSION CONTROLS (December 12, 2003)
  • K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, A (August 15, 2002)
  • K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 (August 15, 2002)
  • K003242 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (November 30, 2000)
  • K003239 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (November 30, 2000)
  • K002865 — LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (September 25, 2000)

FDA data resources