Emd Chemicals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
62
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K031367DUOPATH VEROTOXINS GLISA TESTJanuary 23, 2004
K990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSMarch 31, 1999
K981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSJuly 22, 1998
K973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSOctober 1, 1997
K951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)December 11, 1995
K951750GLUCOSE TEST ITEM NUMBER 97375/94September 6, 1995
K950234TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2June 14, 1995
K950128TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2May 15, 1995
K945322PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416December 7, 1994
K945368PHOSPHORUS TEST (PHOS)December 2, 1994
K840883UNIPAK 100 ANALYZER, 65156 & CHEMISTRMay 16, 1984
K840477UNITIZED HEMATOLOGY SET 65132/93March 5, 1984
K834294ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOBJanuary 24, 1984
K833448EPOS CHEMISTRY ANALYZER 5060 & 6410December 22, 1983
K833017SERUM IRON & TIBC#65084 & 65085November 3, 1983
K832479TRUST RPR CARD TEST #65144September 12, 1983
K832480TRUST RPR TITRATION CARD TEST #65145September 12, 1983
K831027EXTRELUT QE EXTRACTION COLUMNSMay 16, 1983
K831200IMMUNOHEMATOLOGICAL SALINE #97139May 9, 1983
K830832RHEUMATOID FACTOR-RAPID CARD TEST #65114April 18, 1983