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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Medix Biotech, Inc. · Predicate Candidate Screening

39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

45 daysmedian FDA review time
96 days90th percentile
39clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)Medix Biotech, Inc.1995-09-08940
K952319CONTRAST & RAPID HCG URINE/SERUM TSTMedix Biotech, Inc.1995-06-20330
K932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010Medix Biotech, Inc.1994-07-184200
K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITMedix Biotech, Inc.1993-09-281170
K925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1992-12-28610
K924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100Medix Biotech, Inc.1992-11-25930
K922047IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064Medix Biotech, Inc.1992-08-05960
K921700TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093Medix Biotech, Inc.1992-06-29820
K920712MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1992-03-27380
K920345PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)Medix Biotech, Inc.1992-03-18510
K920299MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1992-03-04420
K920504MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1992-03-02260
K920253MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1992-02-14240
K920046MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KITMedix Biotech, Inc.1992-01-28220
K914756ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KITMedix Biotech, Inc.1992-01-15850
K915208FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057Medix Biotech, Inc.1991-12-18300
K914696MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011Medix Biotech, Inc.1991-11-13260
K901345MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050Medix Biotech, Inc.1990-05-10490
K897144THYROXIN(T4) ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1990-03-15780
K896587MODIFIED HCG ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1990-02-16870
K896642MODIFIED LH ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1990-01-30670
K896640MODIFIED FSH ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1990-01-02390
K896643HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015Medix Biotech, Inc.1989-12-29350
K896641MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1989-12-27330
K896585MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1989-12-04130
K894400MICRO-PLATE READER, MDX-1Medix Biotech, Inc.1989-10-23960
K881596FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057Medix Biotech, Inc.1988-05-27450
K874281MEDIX BIOTECH IGE VISUAL SCREENING TEST KITMedix Biotech, Inc.1987-12-18590
K874406IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064Medix Biotech, Inc.1987-11-25280
K873730MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1987-11-04500
K874061TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093Medix Biotech, Inc.1987-11-03290
K873872HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013Medix Biotech, Inc.1987-10-28360
K873355MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KITMedix Biotech, Inc.1987-10-09500
K873668MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1987-10-07270
K872346SURE-STREP A TEST KIT CATALOG NO. MB-1083Medix Biotech, Inc.1987-09-301050
K872794MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KITMedix Biotech, Inc.1987-09-23710
K860490MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAYMedix Biotech, Inc.1986-03-05230
K850949MEDIX VISUAL URINE HCG (7/7) TESTMedix Biotech, Inc.1985-04-12360
K850987MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMMMedix Biotech, Inc.1985-04-08280

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda