Company ยท US
Medix Biotech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1995. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 9 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 4 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 3 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 |
| CFL | Radioimmunoassay, Human Growth Hormone | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 |
| DGC | Ige, Antigen, Antiserum, Control | 2 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | 1 |
| MSJ | Apolipoproteins | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 1995 | K952873 | MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) Medix Biotech, Inc. | GTZ |
| Jun 20, 1995 | K952319 | CONTRAST & RAPID HCG URINE/SERUM TST Medix Biotech, Inc. | JHI |
| Jul 18, 1994 | K932482 | MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 Medix Biotech, Inc. | GTZ |
| Sep 28, 1993 | K932758 | MEDIX BIOTECH BESTEST HCG-URINE TEST KIT Medix Biotech, Inc. | JHI |
| Dec 28, 1992 | K925436 | MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CDP |
| Nov 25, 1992 | K924259 | MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 Medix Biotech, Inc. | JHI |
| Aug 5, 1992 | K922047 | IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 Medix Biotech, Inc. | DGC |
| Jun 29, 1992 | K921700 | TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 Medix Biotech, Inc. | JLW |
| Mar 27, 1992 | K920712 | MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | KLI |
| Mar 18, 1992 | K920345 | PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) Medix Biotech, Inc. | CFT |
| Mar 4, 1992 | K920299 | MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CFL |
| Mar 2, 1992 | K920504 | MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CEP |
| Feb 14, 1992 | K920253 | MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | JHI |
| Jan 28, 1992 | K920046 | MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT Medix Biotech, Inc. | DBF |
| Jan 15, 1992 | K914756 | ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT Medix Biotech, Inc. | JLW |
| Dec 18, 1991 | K915208 | FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 Medix Biotech, Inc. | CGJ |
| Nov 13, 1991 | K914696 | MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 Medix Biotech, Inc. | JHI |
| May 10, 1990 | K901345 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 Medix Biotech, Inc. | CGJ |
| Mar 15, 1990 | K897144 | THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | KLI |
| Feb 16, 1990 | K896587 | MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | JHI |
| Jan 30, 1990 | K896642 | MODIFIED LH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CEP |
| Jan 2, 1990 | K896640 | MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CGJ |
| Dec 29, 1989 | K896643 | HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 Medix Biotech, Inc. | CFL |
| Dec 27, 1989 | K896641 | MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CFT |
| Dec 4, 1989 | K896585 | MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | DBF |
| Oct 23, 1989 | K894400 | MICRO-PLATE READER, MDX-1 Medix Biotech, Inc. | JJX |
| May 27, 1988 | K881596 | FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 Medix Biotech, Inc. | CGJ |
| Dec 18, 1987 | K874281 | MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT Medix Biotech, Inc. | DHB |
| Nov 25, 1987 | K874406 | IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 Medix Biotech, Inc. | DGC |
| Nov 4, 1987 | K873730 | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | JMG |
| Nov 3, 1987 | K874061 | TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 Medix Biotech, Inc. | JLW |
| Oct 28, 1987 | K873872 | HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 Medix Biotech, Inc. | DHA |
| Oct 9, 1987 | K873355 | MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT Medix Biotech, Inc. | CFT |
| Oct 7, 1987 | K873668 | MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CEP |
| Sep 30, 1987 | K872346 | SURE-STREP A TEST KIT CATALOG NO. MB-1083 Medix Biotech, Inc. | GTZ |
| Sep 23, 1987 | K872794 | MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT Medix Biotech, Inc. | MSJ |
| Mar 5, 1986 | K860490 | MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY Medix Biotech, Inc. | JHI |
| Apr 12, 1985 | K850949 | MEDIX VISUAL URINE HCG (7/7) TEST Medix Biotech, Inc. | JHI |
| Apr 8, 1985 | K850987 | MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM Medix Biotech, Inc. | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||