Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

39 results for "Medix Biotech, Inc."
1–24 of 39
Search insights Median review: 45d Cleared: 100% Top manufacturer: Medix Biotech, Inc. Lead specialty: Chemistry
Cleared Sep 08, 1995
MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
K952873 · GTZ
Medix Biotech, Inc.
Microbiology · 94d
Cleared Jun 20, 1995
CONTRAST & RAPID HCG URINE/SERUM TST
K952319 · JHI
Medix Biotech, Inc.
Chemistry · 33d
Cleared Jul 18, 1994
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
K932482 · GTZ
Medix Biotech, Inc.
Microbiology · 420d
Cleared Sep 28, 1993
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT
K932758 · JHI
Medix Biotech, Inc.
Chemistry · 117d
Cleared Dec 28, 1992
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
K925436 · CDP
Medix Biotech, Inc.
Chemistry · 61d
Cleared Nov 25, 1992
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
K924259 · JHI
Medix Biotech, Inc.
Chemistry · 93d
Cleared Aug 05, 1992
IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064
K922047 · DGC
Medix Biotech, Inc.
Immunology · 96d
Cleared Jun 29, 1992
TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093
K921700 · JLW
Medix Biotech, Inc.
Chemistry · 82d
Cleared Mar 27, 1992
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
K920712 · KLI
Medix Biotech, Inc.
Chemistry · 38d
Cleared Mar 18, 1992
PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)
K920345 · CFT
Medix Biotech, Inc.
Chemistry · 51d
Cleared Mar 04, 1992
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT
K920299 · CFL
Medix Biotech, Inc.
Chemistry · 42d
Cleared Mar 02, 1992
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K920504 · CEP
Medix Biotech, Inc.
Chemistry · 26d
Cleared Feb 14, 1992
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT
K920253 · JHI
Medix Biotech, Inc.
Chemistry · 24d
Cleared Jan 28, 1992
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
K920046 · DBF
Medix Biotech, Inc.
Immunology · 22d
Cleared Jan 15, 1992
ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT
K914756 · JLW
Medix Biotech, Inc.
Chemistry · 85d
Cleared Dec 18, 1991
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
K915208 · CGJ
Medix Biotech, Inc.
Chemistry · 30d
Cleared Nov 13, 1991
MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011
K914696 · JHI
Medix Biotech, Inc.
Chemistry · 26d
Cleared May 10, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050
K901345 · CGJ
Medix Biotech, Inc.
Chemistry · 49d
Cleared Mar 15, 1990
THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
K897144 · KLI
Medix Biotech, Inc.
Chemistry · 78d
Cleared Feb 16, 1990
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
K896587 · JHI
Medix Biotech, Inc.
Chemistry · 87d
Cleared Jan 30, 1990
MODIFIED LH ENZYME IMMUNOASSAY TEST KIT
K896642 · CEP
Medix Biotech, Inc.
Chemistry · 67d
Cleared Jan 02, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT
K896640 · CGJ
Medix Biotech, Inc.
Chemistry · 39d
Cleared Dec 29, 1989
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643 · CFL
Medix Biotech, Inc.
Chemistry · 35d
Cleared Dec 27, 1989
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT
K896641 · CFT
Medix Biotech, Inc.
Chemistry · 33d