Icn Pharmaceuticals, Inc.
Costa Mesa, CA, US
Icn Pharmaceuticals, Inc. appears in FDA device records in Costa Mesa, CA. FDA records list 30 510(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
- 30
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for Icn Pharmaceuticals, Inc. between 1977 and 2002. The busiest year on record is 1977, with 21. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 21 |
| 1991 | 7 |
| 1995 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II | GEX | Substantially Equivalent | |
| K951329 | IMMUCHEM GAL-MW EA | JIA | Substantially Equivalent | |
| K914530 | ICAN GT DRAINAGE BAG | FRQ | Substantially Equivalent | |
| K914082 | SUAN FLAT DISSECTOR SPONGES | GDY | Substantially Equivalent | |
| K914086 | ICAN CYLINDRICAL SPONGES | GDX | Substantially Equivalent | |
| K914083 | ICAN K DISSECTOR SPONGES | GDY | Substantially Equivalent | |
| K914081 | ICAN COTTON RAYON BALLS | FRL | Substantially Equivalent | |
| K913446 | ICAN NEEDLE COUNTERS | MMK | Substantially Equivalent | |
| K904398 | WATER COLUMN RELIEF VALVE | CAF | Substantially Equivalent | |
| K770458 | BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. | CIG | Substantially Equivalent | |
| K770457 | CHOLESTEROL PROCEDURE, TEKPOINT TOTAL | CGO | Substantially Equivalent | |
| K770456 | PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT | CEO | Substantially Equivalent | |
| K770455 | GLUCOSE PROCEDURE, TEKPOINT DIRECT | CGE | Substantially Equivalent | |
| K770454 | CREATININE PROCEDURE, TEKPOINT | CGX | Substantially Equivalent | |
| K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | CIO | Substantially Equivalent | |
| K770452 | PROTEIN PROCEDURE, TEKPOINT TOTAL | CEK | Substantially Equivalent | |
| K770451 | ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL | CIX | Substantially Equivalent | |
| K770450 | CHLORIDE PROCEDURE, TEKPOINT DIRECT | CHJ | Substantially Equivalent | |
| K770449 | CALCIUM PROCEDURE, TEKPOINT DIRECT | CIC | Substantially Equivalent | |
| K770459 | URIC ACID PROCEDURE, TEKPOINT DIRECT | CDH | Substantially Equivalent | |
| K770319 | REAGENT CPK, ENZYME | CGS | Substantially Equivalent | |
| K770318 | REAGENT GOT, ENZYME | CIT | Substantially Equivalent | |
| K770315 | BUN, ENZYMATIC | CDQ | Substantially Equivalent | |
| K770313 | REAGENT LDH-L, ENZYME | CFJ | Substantially Equivalent | |
| K770312 | CHEMISTRY CONTROL, ABNORMAL | JJY | Substantially Equivalent | |
| K770310 | CHEMISTRY CONTROL, NORMAL | JJY | Substantially Equivalent | |
| K770317 | GLUCOSE TRINDER, ENZYMATIC | CGA | Substantially Equivalent | |
| K770316 | ALKALINE PHOSPHATASE ENZYMATIC | CJE | Substantially Equivalent | |
| K770314 | REAGENT GPT, ENZYME | CKA | Substantially Equivalent | |
| K770311 | GLUCOSE REAGENT, ENZYMATIC | CFR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDHAcid, Uric, Phosphotungstate Reduction
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- MMKContainer, Sharps
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- JIAEnzymatic Methods, Galactose
- FRLFiber, Medical, Absorbent
- GDYGauze/Sponge, Internal, X-Ray Detectable
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CAFNebulizer (Direct Patient Interface)
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CGEOrthotoluidine, Glucose
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- GEXPowered Laser Surgical Instrument
- GDXScalpel, One-Piece
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- FRQTube, Levine
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
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