Starplex Scientific Corp.
Cleveland, TN, US
STARPLEX SCIENTIFIC CORP. appears in FDA device records in Cleveland, TN. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Starplex Scientific Corp. between 1992 and 2003. The busiest year on record is 1993, with 4. The most recent is 2003, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 4 |
| 1995 | 1 |
| 1996 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032246 | MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | JSM | Substantially Equivalent | |
| K022388 | STARTOX DRUG OF ABUSE SCREENING TEST (4) | DJC | Substantially Equivalent | |
| K021006 | STARTOX DRUG OF ABUSE SCREENING TEST | DKZ | Substantially Equivalent | |
| K962843 | MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | JSM | Substantially Equivalent | |
| K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | LIO | Substantially Equivalent | |
| K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | JSL | Substantially Equivalent | |
| K924364 | VACUPLUS TUBES WITH GREY STOPPERS | JKA | Substantially Equivalent | |
| K924362 | VACUPLUS TUBES WITH LAVANDER STOPPERS | JKA | Substantially Equivalent | |
| K924361 | VACUPLUS TUBES WITH GREEN STOPPERS | JKA | Substantially Equivalent | |
| K924363 | VACUPLUS(R) STAR-SEP(TM) | JKA | Substantially Equivalent | |
| K924365 | VACUPLUS TUBES WITH BRICK RED STOPPERS | JKA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006623380 | 3006623380 | STARPLEX SCIENTIFIC CORP. | 705 Industrial Drive SW, Cleveland, TN 37311 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NNIContainer, Specimen, Non-Sterile
- FMHContainer, Specimen, Sterile
- JSLCulture Media, Anaerobic Transport
- JSMCulture Media, Non-Propagating Transport
- LIODevice, Specimen Collection
- DKZEnzyme Immunoassay, Amphetamine
- DJCThin Layer Chromatography, Methamphetamine
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
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