Hi Chem, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
52
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K960084HICHEM GLUCOSE/HK REAGENT KITApril 4, 1996
K951818HICHEM ALT REAGENT KITMay 15, 1995
K943684HICHEM ENZYME VERIFIER KITOctober 4, 1994
K941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808May 13, 1994
K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDJuly 17, 1990
K863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)October 24, 1986
K862027LDP REAGENT CARTRIDGE (NO. 88216)June 13, 1986
K861893GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)June 5, 1986
K861879CK REAGENT CARTRIDGE (PRODUCT NO. 88213)May 29, 1986
K861231ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)April 28, 1986
K861284AP REAGENT CARTRIDGEApril 28, 1986
K861419HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGEApril 28, 1986
K861283AST REAGENT CARTRIDGEApril 28, 1986
K855196CLEANING REAGENT KIT PRODUCT NO 88194January 22, 1986
K852867HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATEAugust 29, 1985
K853003HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193August 6, 1985
K851350ION 2 REAGENT KIApril 29, 1985
K850405CALIBRATOR B 88133April 1, 1985
K842449HICHEM ION 2/4 SERUM RANGE CALIBRATORAugust 16, 1984
K842450HICHEM ION 2/4 URINE RANGE CALIBRATORAugust 16, 1984