Solarcare Technologies Corp,Inc.
Bethlehem, PA, US
Solarcare Technologies Corp,Inc. appears in FDA device records in Bethlehem, PA. FDA records list 28 510(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
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Solarcare Technologies Corp,Inc. between 1991 and 1996. The busiest year on record is 1993, with 10. The most recent is 1996, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 6 |
| 1993 | 10 |
| 1994 | 1 |
| 1995 | 5 |
| 1996 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954326 | STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY | JIT | Substantially Equivalent | |
| K954156 | STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY | KQO | Substantially Equivalent | |
| K955905 | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | CEK | Substantially Equivalent | |
| K954158 | STC DIAGNOSTICS AUTO-LYTE PH ASSAY | KQO | Substantially Equivalent | |
| K940048 | STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION | DLJ | Substantially Equivalent | |
| K954073 | STC DIAGNOSTICS LSD MICRO-PLATE EIA | DLB | Substantially Equivalent | |
| K954266 | STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY | CGX | Substantially Equivalent | |
| K935573 | AMPHETAMINES MICRO-PLATE EIA | DKZ | Substantially Equivalent | |
| K935565 | OPIATES MICRO-PLATE ASSAY | DJG | Substantially Equivalent | |
| K950308 | STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA | JXS | Substantially Equivalent | |
| K944056 | AUTO-LYTE METHADONE DIA | DJR | Substantially Equivalent | |
| K934869 | STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA | JXM | Substantially Equivalent | |
| K931299 | HISTOFREEZER | GEH | Substantially Equivalent | |
| K931498 | SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY | DKZ | Substantially Equivalent | |
| K931516 | STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY | DIC | Substantially Equivalent | |
| K930654 | STC DIAGNOSTICS AUTO-LYTE CANNABINOIDS EIA | LDJ | Substantially Equivalent | |
| K930690 | STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA | DKZ | Substantially Equivalent | |
| K923532 | NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY | JLW | Substantially Equivalent | |
| K925649 | NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY | CEC | Substantially Equivalent | |
| K924114 | HISTOFREEZER | GEH | Substantially Equivalent | |
| K924815 | MICROPLATE CANNABINOIDS ASSAY | LDJ | Substantially Equivalent | |
| K924751 | SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY | LCM | Substantially Equivalent | |
| K924462 | STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA | LCM | Substantially Equivalent | |
| K924446 | MICRO-PLATE OPIATES ASSAY | DJG | Substantially Equivalent | |
| K921328 | STC DIAGNOSTICS AUTO-LYTE OPIATE EIA | DJG | Substantially Equivalent | |
| K921140 | STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA | JXO | Substantially Equivalent | |
| K915785 | STC DIAGNOSTICS BENZOYLECGONINE EIA | JXO | Substantially Equivalent | |
| K911420 | HISTOFREEZER | GEH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- CGXAlkaline Picrate, Colorimetry, Creatinine
- KQOAutomated Urinalysis System
- CEKBiuret (Colorimetric), Total Protein
- JXSBlock, Cutting, Ent, Sterile
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- DKZEnzyme Immunoassay, Amphetamine
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- JXOEnzyme Immunoassay, Cocaine
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- CECRadioimmunoassay, Free Thyroxine
- DLBRadioimmunoassay, Lsd (125-I)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- GEHUnit, Cryosurgical, Accessories
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