Alpha-Tec Systems, Inc.
Vancouver, WA, US
Alpha-Tec Systems, Inc. appears in FDA device records in Vancouver, WA. 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 Alpha-Tec Systems, Inc. between 1983 and 2006. The busiest year on record is 1988, with 10. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 3 |
| 1988 | 10 |
| 1989 | 4 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K053257 | PARA-PRO FC50 | LKS | Substantially Equivalent | |
| K890861 | ATS DOBELL & O'CONNOR'S IODINE | JTS | Substantially Equivalent | |
| K890020 | ATS LUGOL'S IODINE SOLUTION | JTS | Substantially Equivalent | |
| K890148 | ATS TB RAPID STAIN SET PRODUCT #034-45 | ICL | Substantially Equivalent | |
| K890022 | ATS MAYER'S ALBUMIN | KEL | Substantially Equivalent | |
| K883049 | ATS PARA-SET IODINE ALCOHOL SOLUTION | JTS | Substantially Equivalent | |
| K883048 | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION | LDZ | Substantially Equivalent | |
| K883062 | ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID | LDW | Substantially Equivalent | |
| K881949 | ATS NAC-PAC SET | JSK | Substantially Equivalent | |
| K881879 | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | JSK | Substantially Equivalent | |
| K881698 | ATS PVA FIXATIVE SOLUTION | LDZ | Substantially Equivalent | |
| K880989 | ATS CRYPTOSPORIDIUM STAIN SET | JTS | Substantially Equivalent | |
| K881042 | ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) | JTS | Substantially Equivalent | |
| K880962 | ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES | LJG | Substantially Equivalent | |
| K880990 | ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION | JSY | Substantially Equivalent | |
| K823706 | ATS AFB STAIN CONTROL SLIDE | LJG | Substantially Equivalent | |
| K823705 | ATS PARASITOLOGY STAIN CONTROL SLIDE | LJG | Substantially Equivalent | |
| K823704 | ATS GRAM STAIN CONTROL SLIDE | LJG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain