In Vitro Diagnostics, Inc.
Shelton, CT, US
In Vitro Diagnostics, Inc. appears in FDA device records in Shelton, CT. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for In Vitro Diagnostics, Inc. between 1985 and 1990. The busiest year on record is 1987, with 8. The most recent is 1990, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1987 | 8 |
| 1990 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K896867 | THYROID STIMULATING HORMONE-EIA-XT | JLW | Substantially Equivalent | |
| K896866 | LUTEINIZING HORMONE-EIA-XT | CEP | Substantially Equivalent | |
| K896863 | DIGOXIN-EIA-XT | KXT | Substantially Equivalent | |
| K896865 | VITRO T4-EIA-XT | KLI | Substantially Equivalent | |
| K896925 | T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT | KHQ | Substantially Equivalent | |
| K896864 | FOLLICLE STIMULATING HORMONE-EIA-XT | CGJ | Substantially Equivalent | |
| K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | KRZ | Substantially Equivalent | |
| K871188 | LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 | JIS | Substantially Equivalent | |
| K871187 | LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 | JIS | Substantially Equivalent | |
| K871186 | CESIUM DILUENT 1.5 MMOL CS/L #60087 | JIS | Substantially Equivalent | |
| K871185 | LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 | JIS | Substantially Equivalent | |
| K871184 | FLAME PHOTOMETER STANDARD #60083 160 NA/8K | JIX | Substantially Equivalent | |
| K871183 | FLAME PHOTOMETER STANDARD #60082 140 NA/5K | JIX | Substantially Equivalent | |
| K871182 | FLAME PHOTOMETER STANDARD #60081 120 NA/2K | JIX | Substantially Equivalent | |
| K853304 | 21 HEMATOLOGY REAGENTS | GKZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- GKZCounter, Differential Cell
- KXTEnzyme Immunoassay, Digoxin
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- KHQRadioassay, Triiodothyronine Uptake
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
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