Photec Diagnostics, Inc.
Little Falls, NJ, US
Photec Diagnostics, Inc. appears in FDA device records in Little Falls, NJ. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Photec Diagnostics, Inc. between 1985 and 1990. The busiest year on record is 1989, with 5. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 3 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 5 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K897169 | QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT | CDT | Substantially Equivalent | |
| K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. | KLI | Substantially Equivalent | |
| K894057 | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT | LBS | Substantially Equivalent | |
| K892224 | D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN | KHQ | Substantially Equivalent | |
| K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA | CHH | Substantially Equivalent | |
| K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD | CHH | Substantially Equivalent | |
| K882307 | D-CHEM | JJE | Substantially Equivalent | |
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | LCA | Substantially Equivalent | |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | DER | Substantially Equivalent | |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | DER | Substantially Equivalent | |
| K853174 | APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN | MSJ | Substantially Equivalent | |
| K851649 | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | DER | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- MSJApolipoproteins
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- KHQRadioassay, Triiodothyronine Uptake
- LCARadioimmunoassay, Theophylline
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.
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Data as of , FDA export datePage updated Source: openFDA, public domain