Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·PRO-TRAC II TACROLIMUS ELISA KIT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity i Anti-HCV Reagent Kit

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HBV CALIBRATOR KIT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·OraQuick HCV Rapid Antibody Test

EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SAS HCG-CHECK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EZ SURE URINE DIPSTICK PREGNANCY HOME TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO E.P.T. PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPT CERTAINTY PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PURE-AID PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PTK PLUS. HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EARLY PREGNANCY DETECTION TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHOICE ACCU-TEST PREGNANCY TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EVATEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry