Home / 510(k) Clearances / K802162

510(k) K802162

CO2 COLOR REAGENT & CO2 SAMPLE DILUENT by Panmed, Inc. — Product Code KMS

K802162 is an FDA 510(k) premarket notification submitted by Panmed, Inc. for the device "CO2 COLOR REAGENT & CO2 SAMPLE DILUENT". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code KMS (Phenolphthalein Colorimetry, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Panmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phenolphthalein Colorimetry, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by Panmed, Inc.

  • K852767 — ERYTHOCYTE CREATINE (November 13, 1986)
  • K820642 — SICKLE-CHECK (April 14, 1982)
  • K802161 — BIURET REAGENT & TOTAL PROTEIN BLANK SOL (October 10, 1980)
  • K802158 — POSTASSIUM BUFFER SOL. & WASH SOLUTION (October 10, 1980)
  • K802157 — BCG REAGENT SERUM ALBUMIN W/TECHNICON (October 10, 1980)
  • K802163 — CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT (October 10, 1980)
  • K802155 — REAGENTS SERUM SODIUM USING THE TECH. (October 10, 1980)
  • K802160 — BUN COLOR REAGENT & BUN ACID USED (October 10, 1980)
  • K802154 — REAGENTS USED-QUAN. MEASURE OF SERUM (October 10, 1980)
  • K802156 — REAGENTS SERUM CREATINE USING TECHICON (October 10, 1980)

Other clearances for product code KMS

  • K872886 — CARBON DIOXIDE (August 13, 1987)
  • K870025 — AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (March 13, 1987)
  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)

FDA data resources