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510(k) K822132

DADE CHILL TRAY by American Dade — Product Code JRR

K822132 is an FDA 510(k) premarket notification submitted by American Dade for the device "DADE CHILL TRAY". The FDA issued a decision of Substantially Equivalent on August 5, 1982. The device falls under product code JRR (Regulator, Temperature), a Class I device regulated under 21 CFR 862.2050. American Dade has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1982
Date Received
July 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Temperature
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by American Dade

  • K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY (October 20, 1987)
  • K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (September 29, 1987)
  • K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY (September 14, 1987)
  • K872789 — PARAMAX URINE/CSF CALIBRATOR (September 2, 1987)
  • K872195 — DATA-FI DIMERTEST LATEX ASSAY (August 6, 1987)
  • K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (July 31, 1987)
  • K871972 — STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (July 21, 1987)
  • K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (July 9, 1987)
  • K872050 — PARAMAX CHOLESTEROL REAGENT (July 7, 1987)
  • K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (July 6, 1987)

Other clearances for product code JRR

  • K801148 — HEMOGASTAT (June 9, 1980)
  • K780757 — KRYORACK/4 (June 6, 1978)
  • K761337 — AQUAMATIC K-MODULE MODEL K-10 (January 10, 1977)

FDA data resources