Applications Lab
Scarborough, ME, US
Applications Lab appears in FDA device records in Scarborough, ME. FDA records list 10 510(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
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Applications Lab in 1985.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 10 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K850587 | SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN | DEM | Substantially Equivalent | |
| K850586 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M | DAO | Substantially Equivalent | |
| K850603 | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | DEB | Substantially Equivalent | |
| K850589 | SPQ TEST SYSTEM FOR TRANSFERRIN | DDG | Substantially Equivalent | |
| K850588 | SPQ TEST SYSTEM FOR COMPLEMENT C3 | CZW | Substantially Equivalent | |
| K850584 | SPQ TEST SYSTEM FOR HAPTOGLOBIN | DAD | Substantially Equivalent | |
| K850590 | SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN | DCK | Substantially Equivalent | |
| K850585 | SPQ TEST SYSTEM FOR COMPLEMENT C4 | DBI | Substantially Equivalent | |
| K850583 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G | DEW | Substantially Equivalent | |
| K850582 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A | CZP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- DADHaptoglobin, Antigen, Antiserum, Control
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control
- 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.
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Data as of , FDA export datePage updated Source: openFDA, public domain