Medix Biotech, Inc.
Redwood City, CA, US
Medix Biotech, Inc. appears in FDA device records in Redwood City, CA. FDA records list 39 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 39
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 39 510(k) clearances for Medix Biotech, Inc. between 1985 and 1995. The busiest year on record is 1992, with 11. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 9 |
| 1988 | 1 |
| 1989 | 4 |
| 1990 | 5 |
| 1991 | 2 |
| 1992 | 11 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K952873 | MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) | GTZ | Substantially Equivalent | |
| K952319 | CONTRAST & RAPID HCG URINE/SERUM TST | JHI | Substantially Equivalent | |
| K932482 | MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 | GTZ | Substantially Equivalent | |
| K932758 | MEDIX BIOTECH BESTEST HCG-URINE TEST KIT | JHI | Substantially Equivalent | |
| K925436 | MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT | CDP | Substantially Equivalent | |
| K924259 | MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 | JHI | Substantially Equivalent | |
| K922047 | IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 | DGC | Substantially Equivalent | |
| K921700 | TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 | JLW | Substantially Equivalent | |
| K920712 | MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT | KLI | Substantially Equivalent | |
| K920345 | PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) | CFT | Substantially Equivalent | |
| K920299 | MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT | CFL | Substantially Equivalent | |
| K920504 | MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT | CEP | Substantially Equivalent | |
| K920253 | MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT | JHI | Substantially Equivalent | |
| K920046 | MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT | DBF | Substantially Equivalent | |
| K914756 | ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT | JLW | Substantially Equivalent | |
| K915208 | FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 | CGJ | Substantially Equivalent | |
| K914696 | MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 | JHI | Substantially Equivalent | |
| K901345 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 | CGJ | Substantially Equivalent | |
| K897144 | THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT | KLI | Substantially Equivalent | |
| K896587 | MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT | JHI | Substantially Equivalent | |
| K896642 | MODIFIED LH ENZYME IMMUNOASSAY TEST KIT | CEP | Substantially Equivalent | |
| K896640 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT | CGJ | Substantially Equivalent | |
| K896643 | HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 | CFL | Substantially Equivalent | |
| K896641 | MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT | CFT | Substantially Equivalent | |
| K896585 | MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT | DBF | Substantially Equivalent | |
| K894400 | MICRO-PLATE READER, MDX-1 | JJX | Substantially Equivalent | |
| K881596 | FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 | CGJ | Substantially Equivalent | |
| K874281 | MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT | DHB | Substantially Equivalent | |
| K874406 | IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 | DGC | Substantially Equivalent | |
| K873730 | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT | JMG | Substantially Equivalent | |
| K874061 | TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 | JLW | Substantially Equivalent | |
| K873872 | HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 | DHA | Substantially Equivalent | |
| K873355 | MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT | CFT | Substantially Equivalent | |
| K873668 | MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT | CEP | Substantially Equivalent | |
| K872346 | SURE-STREP A TEST KIT CATALOG NO. MB-1083 | GTZ | Substantially Equivalent | |
| K872794 | MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT | MSJ | Substantially Equivalent | |
| K860490 | MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY | JHI | Substantially Equivalent | |
| K850949 | MEDIX VISUAL URINE HCG (7/7) TEST | JHI | Substantially Equivalent | |
| K850987 | MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM | JHI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GTZAntisera, All Groups, Streptococcus Spp.
- MSJApolipoproteins
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DBFFerritin, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHASystem, Test, Human Chorionic Gonadotropin
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain