Cirrus Diagnostics, Inc.
Chester, NJ, US
Cirrus Diagnostics, Inc. appears in FDA device records in Chester, NJ. 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 Cirrus Diagnostics, Inc. between 1991 and 1992. The busiest year on record is 1991, with 8. The most recent is 1992, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 8 |
| 1992 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K921704 | IMMULITE(R) FSH | CGJ | Substantially Equivalent | |
| K920411 | IMMULITE HLH | CEP | Substantially Equivalent | |
| K914833 | IMMULITE DIGOXIN | DPO | Substantially Equivalent | |
| K911796 | IMMULITE(TM) HCG | DHA | Substantially Equivalent | |
| K910677 | IMMULITE(TM) T-UPTAKE | CEE | Substantially Equivalent | |
| K910261 | IMMULITE(TM) TOTAL T4 | KLI | Substantially Equivalent | |
| K905648 | CRP LIPID REAGENT TEST PACK | CHH | Substantially Equivalent | |
| K905214 | IMMULITE (TM) TOTAL T3 | CDP | Substantially Equivalent | |
| K905769 | IMMULITE HS-TSH | JLW | Substantially Equivalent | |
| K905215 | IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER | JJQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDPRadioimmunoassay, Total Triiodothyronine
- DHASystem, Test, Human Chorionic Gonadotropin
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