Antibodies, Inc.
Mchenry, IL, US
Antibodies, Inc. appears in FDA device records in Mchenry, IL. FDA records list 16 510(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
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Antibodies, Inc. between 1977 and 1989. The busiest year on record is 1978, with 5. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 5 |
| 1979 | 1 |
| 1980 | 2 |
| 1981 | 2 |
| 1982 | 1 |
| 1984 | 1 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K890774 | GIARDEIA(TM) | KHW | Substantially Equivalent | |
| K843590 | DETECT-A-STREP | GTZ | Substantially Equivalent | |
| K822892 | CORTISOL RIA KIT | CGR | Substantially Equivalent | |
| K812749 | ULTRA-DIG | LCS | Substantially Equivalent | |
| K812314 | CRITHIDNA ANTI-DNA TEST KIT | DHN | Substantially Equivalent | |
| K802877 | AMIKACIN RIA KIT | KLQ | Substantially Equivalent | |
| K800743 | TOBRAMYCIN RIA KIT | KLB | Substantially Equivalent | |
| K791217 | TSH RIA KIT | JLW | Substantially Equivalent | |
| K781656 | NEPHELRATE ANTISERUMS, IGG | CFN | Substantially Equivalent | |
| K781655 | NEPHELRATE ANTISERUMS 1GA | CFN | Substantially Equivalent | |
| K781654 | NEPHELRATE ANTIPERUMS LGM | CFN | Substantially Equivalent | |
| K781653 | NEPHELRATE ANTISERUMS C3C | CZW | Substantially Equivalent | |
| K780516 | GENTAMICIN RIA KIT | DJB | Substantially Equivalent | |
| K772122 | T3 RIA KIT | CDP | Substantially Equivalent | |
| K771877 | DIGOXIN RIA KIT | DNJ | Substantially Equivalent | |
| K771585 | T3 UPTAKE DIAG. KIT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GTZAntisera, All Groups, Streptococcus Spp.
- CZWComplement C3, Antigen, Antiserum, Control
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- KLQRadioimmunoassay, Amikacin
- CGRRadioimmunoassay, Cortisol
- LCSRadioimmunoassay, Digoxin (125-I)
- DNJRadioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
- DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- KLBRadioimmunoassay, Tobramycin
- CDPRadioimmunoassay, Total Triiodothyronine
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 Antibodies, 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 Antibodies, 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