Intl. Immunoassay Laboratories, Inc.
Mchenry, IL, US
Intl. Immunoassay Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 27 510(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
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Intl. Immunoassay Laboratories, Inc. between 1980 and 1992. The busiest year on record is 1981, with 6. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 6 |
| 1982 | 2 |
| 1984 | 1 |
| 1987 | 3 |
| 1988 | 6 |
| 1989 | 2 |
| 1990 | 3 |
| 1991 | 2 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MB | JHX | Substantially Equivalent | |
| K913349 | STAMBI-CK | JHW | Substantially Equivalent | |
| K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | JHW | Substantially Equivalent | |
| K903441 | MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS | JHX | Substantially Equivalent | |
| K903508 | LABELLING CHANGES TO IMPRES-MB-X | JHW | Substantially Equivalent | |
| K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | JHT | Substantially Equivalent | |
| K890609 | IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) | CGS | Substantially Equivalent | |
| K890543 | IMPRES-MB REAGENT A AND REAGENT B | JHX | Substantially Equivalent | |
| K883432 | IMMUNOCCULT-LXI | KHE | Substantially Equivalent | |
| K883223 | CHECK-MM | JHS | Substantially Equivalent | |
| K883222 | ISOFOR-MM (TM) | JHW | Substantially Equivalent | |
| K871143 | IMMUNOCCULT EIA TEST KIT | KHE | Substantially Equivalent | |
| K881801 | IMPRES-MB | JHW | Substantially Equivalent | |
| K881351 | IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225 | JHY | Substantially Equivalent | |
| K874545 | IMACK-MB TEST PROCEDURE (MODIFICATION) | JHY | Substantially Equivalent | |
| K872598 | MICROMI-CK(TM) | JHT | Substantially Equivalent | |
| K872592 | IMACK-MB(TM) | JHT | Substantially Equivalent | |
| K843007 | CARDI-CK EIA TEST KIT CK-MB ISOENZYME | JHS | Substantially Equivalent | |
| K821963 | EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. | GGP | Substantially Equivalent | |
| K821964 | 125I QUICK-MB TEST KIT FOR QUANTITATION | JHT | Substantially Equivalent | |
| K813213 | SHARIA-LH RIA KIT FOR QUANTITATION HORMO | CEP | Substantially Equivalent | |
| K813087 | ABURIA-CK RIA TEST KIT | JHX | Substantially Equivalent | |
| K813086 | ANDRIA-FSH RIA TEST KIT | CGJ | Substantially Equivalent | |
| K812671 | EMBRITROL CK-MB CONTROLS | JJT | Substantially Equivalent | |
| K812112 | MARRIA-HPRL RIA KIT | CFT | Substantially Equivalent | |
| K811070 | 125 I-T4 RIA TEST KIT | CDX | Substantially Equivalent | |
| K801728 | EMBRIA-CK | JHX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHTChromatographic Separation, Cpk Isoenzymes
- JHYColorimetric Method, Cpk Or Isoenzymes
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- JJTEnzyme Controls (Assayed And Unassayed)
- JHXFluorometric Method, Cpk Or Isoenzymes
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDXRadioimmunoassay, Total Thyroxine
- KHEReagent, Occult Blood
- GGPTest, Qualitative And Quantitative Factor Deficiency
- JHWU.V. Method, Cpk Isoenzymes
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 Intl. Immunoassay Laboratories, 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 Intl. Immunoassay Laboratories, 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