Princeton Biomedix
Mchenry, IL, US
Princeton Biomedix appears in FDA device records in Mchenry, IL. FDA records list 14 510(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
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Princeton Biomedix between 1976 and 1995. The busiest year on record is 1976, with 4. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 1 |
| 1989 | 3 |
| 1990 | 1 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K942052 | LIFESIGN MI MYOGLOBIN | DDR | Substantially Equivalent | |
| K925355 | BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST | LFX | Substantially Equivalent | |
| K930185 | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP | CEP | Substantially Equivalent | |
| K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST | KTN | Substantially Equivalent | |
| K926308 | LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST | LCX | Substantially Equivalent | |
| K901011 | BIOSIGN HCG-ONE STEP PREGNANCY TEST | JHI | Substantially Equivalent | |
| K894750 | BIOSTIX I. HCG - ONE STEP PREGNANCY TEST | JHI | Substantially Equivalent | |
| K894705 | BIOSPOT HCG-RAPID PREGNANCY TEST | JHI | Substantially Equivalent | |
| K892654 | BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST | DHA | Substantially Equivalent | |
| K761315 | ALKALINE PHOSPHATASE (ALP)/PNPP | CJE | Substantially Equivalent | |
| K760346 | ASSAY FOR GAMMA GLUTAMYLTRANSFERASE | JPZ | Substantially Equivalent | |
| K760345 | TEST, LACTATE DEHYDROGENASE | CFJ | Substantially Equivalent | |
| K760347 | SET, TRINDER GLUCOSE | CGA | Substantially Equivalent | |
| K760161 | TEST, ACID PHOSPHATASE | CJR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CJRAcid Phosphatase, Thymol Blue Monophosphate
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- CGAGlucose Oxidase, Glucose
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- DDRMyoglobin, Antigen, Antiserum, Control
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEPRadioimmunoassay, Luteinizing Hormone
- DHASystem, Test, Human Chorionic Gonadotropin
- KTNSystem, Test, Infectious Mononucleosis
- 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 Princeton Biomedix 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 Princeton Biomedix. 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