Wellcome Diagnostics
Walker, MI, US
Wellcome Diagnostics appears in FDA device records in Walker, MI. FDA records list 28 510(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
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Wellcome Diagnostics between 1983 and 1992. The busiest year on record is 1983, with 8. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 8 |
| 1984 | 7 |
| 1985 | 3 |
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K915203 | D-DIMER WELLCOTEST (HA10) | DAP | Substantially Equivalent | |
| K910797 | STREPTEX ACID EXTRACTION KIT | GTZ | Substantially Equivalent | |
| K895461 | WELLCOLEX COLOUR SHIGELLA TEST ZC51 | GNB | Substantially Equivalent | |
| K890146 | WELLCOLEX COLOUR SALMONELLA TEST ZL 50 | GRM | Substantially Equivalent | |
| K875311 | WELLCOZYME HSV WZO2 | GQN | Substantially Equivalent | |
| K861628 | WELLCOZYME ROTAVIRUS WZ01 | LIQ | Substantially Equivalent | |
| K864206 | REVEAL COLOUR STREP A ZL16 | GTZ | Substantially Equivalent | |
| K861634 | THE WELLCOME ROTAVIRUS LATEX TEST ZL40 | LIQ | Substantially Equivalent | |
| K854852 | WELLCOGEN BACTERIAL ANTIGEN KIT | GTJ | Substantially Equivalent | |
| K854851 | WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 | GTJ | Substantially Equivalent | |
| K851691 | WILLCOGEN MENINGITIDIS KIT ZL25 | GTJ | Substantially Equivalent | |
| K844762 | MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 | GTJ | Substantially Equivalent | |
| K851949 | STAPHAUREX ZL30 | GTN | Substantially Equivalent | |
| K842827 | STREPTEX DIRECT A ZL14 | GTZ | Substantially Equivalent | |
| K842828 | STREPTEX ZL01 | JTO | Substantially Equivalent | |
| K841376 | WELLCOGEN S. PNEUMONIAE | GWC | Substantially Equivalent | |
| K840210 | REPTILASE-R HA35 | JCO | Substantially Equivalent | |
| K840211 | FIBRI-PREST AUTOMATE HA34 | KQJ | Substantially Equivalent | |
| K833077 | WELLCOGEN H. INFLUENZAL ZL21 | GRD | Substantially Equivalent | |
| K833063 | WELLCOGEN N. MENINGITIDIS A,C,Y W135 | GTJ | Substantially Equivalent | |
| K832591 | DIACROM *PLG | DDX | Substantially Equivalent | |
| K832592 | DIACROM * ATIII | JBQ | Substantially Equivalent | |
| K832373 | DIACROM * HEPARIN | KFF | Substantially Equivalent | |
| K832372 | DIACROM * FACTOR X KIT HA31 | GGP | Substantially Equivalent | |
| K831073 | DAC-CEL HCG-MCA KIT RD52 | CFL | Substantially Equivalent | |
| K831069 | DAC-CEL PTH KIT RD51 | CEW | Substantially Equivalent | |
| K830204 | DAC-CEL DIAGNATAL HCG STANDARDS RD49 | JJX | Substantially Equivalent | |
| K830203 | DAC-CEL DIAGNATAL RD 50 | JHI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GTJAntisera, All Groups, N. Meningitidis
- GRMAntisera, All Groups, Salmonella Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- GNBAntisera, All Types, Shigella Spp.
- GWCAntisera, All Types, Streptococcus Pneumoniae
- GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.
- GRDAntiserum, Hai, Mumps Virus
- JBQAntithrombin Iii Quantitation
- KFFAssay, Heparin
- JCOBothrops Atrox Reagent
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- DDXPlasminogen, Antigen, Antiserum, Control
- CFLRadioimmunoassay, Human Growth Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KQJSystem, Fibrinogen Determination
- GGPTest, Qualitative And Quantitative Factor Deficiency
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Wellcome Diagnostics edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Wellcome Diagnostics. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain