Pcl-Ria, Inc.
Mchenry, IL, US
Pcl-Ria, Inc. appears in FDA device records in Mchenry, IL. FDA records list 29 510(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
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Pcl-Ria, Inc. between 1977 and 1983. The busiest year on record is 1978, with 11. The most recent is 1983, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 11 |
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 6 |
| 1982 | 6 |
| 1983 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K830526 | B-GCG SYSTEM BY RIA | JHI | Substantially Equivalent | |
| K823014 | DIGOXIN KIT | DPB | Substantially Equivalent | |
| K822935 | THYROID STIMULATING HORMONE | JLW | Substantially Equivalent | |
| K822612 | T3 UPTAKE KITS | KHQ | Substantially Equivalent | |
| K820886 | THYROXINE T4 KIT | CDX | Substantially Equivalent | |
| K820358 | FOLLICLE STIMULATING HORMONE KIT | CGJ | Substantially Equivalent | |
| K820357 | LUTEINIZING HORMONE KIT | CEP | Substantially Equivalent | |
| K812666 | THYROXINE (T4) 125I | CDP | Substantially Equivalent | |
| K810867 | FOLLICLE STIMULATING HORMONE (FSH) | JIS | Substantially Equivalent | |
| K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM | CGJ | Substantially Equivalent | |
| K810754 | LUTENIZING HORMONES | CEP | Substantially Equivalent | |
| K810741 | LUTEINIZING HORMONE | CEP | Substantially Equivalent | |
| K803180 | 1-125 LABELED TRIIODOTHYRONINE(T3) | CDP | Substantially Equivalent | |
| K803047 | I-125 LABELED DIGOXIN | LCS | Substantially Equivalent | |
| K790876 | LABELED HUMAN CHORIONIC GONADOTROPHIN | JHI | Substantially Equivalent | |
| K790864 | RABBIT ANTISERUM TO HUMAN CHORIONIC | JHI | Substantially Equivalent | |
| K790863 | HUMAN CHORIONIC GONADOTROPHIN STANDARDS | JHI | Substantially Equivalent | |
| K781284 | RABBIT ANTIBODY TO HUMAN T3 | CDP | Substantially Equivalent | |
| K781071 | STANDARDS, HORMONE, THYROID STIMULATING | JIT | Substantially Equivalent | |
| K781069 | T3 STANDARDS IN HUMAN SERUM | JIT | Substantially Equivalent | |
| K780889 | DIGOXIN STANDARDS IN HUMAN SERUM | DMP | Substantially Equivalent | |
| K781070 | SECOND ANTIBODY | KTS | Substantially Equivalent | |
| K780576 | 125-I LABELED HUMAN LUTEINIZING HORMONE | CEP | Substantially Equivalent | |
| K780316 | RABBIT ANTIBODY TO DIGOXIN | DKA | Substantially Equivalent | |
| K780059 | RABBIT ANTIBODY/THYROID STIMUL. HORMONE | JLW | Substantially Equivalent | |
| K780050 | THYROXINE STDS. IN HUMAN SERUM | CDX | Substantially Equivalent | |
| K780015 | THYROID STIMULATING HORMONE | JLW | Substantially Equivalent | |
| K780016 | HUMAN FOLLICLE STIMULATING HORMONE | CGI | Substantially Equivalent | |
| K772096 | IN VITRO DIAGNOSTIC REAGENT | CDX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DKAAntiserum, Digoxin
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DMPDigoxin Control Serum, Ria
- KHQRadioassay, Triiodothyronine Uptake
- LCSRadioimmunoassay, Digoxin (125-I)
- DPBRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- KTSSecond Antibody (Species Specific Anti-Animal Gamma Globulin)
- 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 Pcl-Ria, Inc. 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 Pcl-Ria, Inc.. 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
