Atlantic Antibodies
Mchenry, IL, US
Atlantic Antibodies appears in FDA device records in Mchenry, IL. FDA records list 18 510(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
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Atlantic Antibodies between 1983 and 1989. The busiest year on record is 1989, with 10. The most recent is 1989, with 10.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 10 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K892526 | SPQ TM TEST SYSTEM II FOR CRP | DCK | Substantially Equivalent | |
| K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B | MSJ | Substantially Equivalent | |
| K890563 | SPQ(TM) ANTIBODY REAGENT SET II FOR TRF | DDG | Substantially Equivalent | |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | CFQ | Substantially Equivalent | |
| K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | DAD | Substantially Equivalent | |
| K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG | DEW | Substantially Equivalent | |
| K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | DBI | Substantially Equivalent | |
| K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | KTQ | Substantially Equivalent | |
| K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | DEM | Substantially Equivalent | |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | CZP | Substantially Equivalent | |
| K884298 | SPQ(TM) TEST SYSTEM FOR MICROALBUMIN | JZJ | Substantially Equivalent | |
| K884297 | SPQ(TM) TEST SYSTEM FOR PREALBUMIN | JZJ | Substantially Equivalent | |
| K881898 | MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B | MSJ | Substantially Equivalent | |
| K870862 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL | MSJ | Substantially Equivalent | |
| K870564 | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B | MSJ | Substantially Equivalent | |
| K861167 | IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST | CZP | Substantially Equivalent | |
| K851842 | SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN | DCK | Substantially Equivalent | |
| K833119 | AUTOIMMUNE TEST 1/2/3 SYSTEM | DHN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- MSJApolipoproteins
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DBIComplement C4, Antigen, Antiserum, Control
- DADHaptoglobin, Antigen, Antiserum, Control
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- JZJPrealbumin, Antigen, Antiserum, Control
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)
- KTQReagent, Complement
- DDGTransferrin, Antigen, Antiserum, Control
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 Atlantic Antibodies 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 Atlantic Antibodies. 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