Medical Device Manufacturer · US , Mchenry , IL

Emd Chemicals, Inc. - FDA 510(k) Cleared Devices

62 submissions · 62 cleared · Since 1982

62

Total

62

Cleared

0

Denied

FDA 510(k) Regulatory Record - Emd Chemicals, Inc. Chemistry ✕

49 devices

1-12 of 49

Cleared Dec 11, 1995

AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)

Chemistry · 255d

Cleared Sep 06, 1995

GLUCOSE TEST ITEM NUMBER 97375/94

Chemistry · 142d

Cleared Jun 14, 1995

TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2

Chemistry · 152d

Cleared May 15, 1995

TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2

Chemistry · 123d

Cleared Dec 07, 1994

PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416

Chemistry · 36d

Cleared Dec 02, 1994

PHOSPHORUS TEST (PHOS)

Chemistry · 43d

Cleared May 16, 1984

UNIPAK 100 ANALYZER, 65156 & CHEMISTR

Chemistry · 79d

Cleared Dec 22, 1983

EPOS CHEMISTRY ANALYZER 5060 & 6410

Chemistry · 78d

Cleared Nov 03, 1983

SERUM IRON & TIBC#65084 & 65085

Chemistry · 58d

Cleared May 09, 1983

IMMUNOHEMATOLOGICAL SALINE #97139

Chemistry · 28d

Cleared Apr 05, 1983

ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA

Chemistry · 70d

Cleared Apr 05, 1983

ULTRA CHEM BUN-UV #65080-65081

Chemistry · 70d

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