Company ยท US
Icn Pharmaceuticals, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2002. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGE | Orthotoluidine, Glucose | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 2002 | K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II Icn Pharmaceuticals, Inc. | GEX |
| Nov 9, 1995 | K951329 | IMMUCHEM GAL-MW EA Icn Pharmaceuticals, Inc. | JIA |
| Dec 18, 1991 | K914530 | ICAN GT DRAINAGE BAG Icn Pharmaceuticals, Inc. | FRQ |
| Nov 27, 1991 | K914082 | SUAN FLAT DISSECTOR SPONGES Icn Pharmaceuticals, Inc. | GDY |
| Oct 9, 1991 | K914086 | ICAN CYLINDRICAL SPONGES Icn Pharmaceuticals, Inc. | GDX |
| Oct 9, 1991 | K914083 | ICAN K DISSECTOR SPONGES Icn Pharmaceuticals, Inc. | GDY |
| Oct 9, 1991 | K914081 | ICAN COTTON RAYON BALLS Icn Pharmaceuticals, Inc. | FRL |
| Sep 13, 1991 | K913446 | ICAN NEEDLE COUNTERS Icn Pharmaceuticals, Inc. | MMK |
| Jul 9, 1991 | K904398 | WATER COLUMN RELIEF VALVE Icn Pharmaceuticals, Inc. | CAF |
| May 10, 1977 | K770458 | BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. Icn Pharmaceuticals, Inc. | CIG |
| May 3, 1977 | K770457 | CHOLESTEROL PROCEDURE, TEKPOINT TOTAL Icn Pharmaceuticals, Inc. | CGO |
| May 3, 1977 | K770456 | PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. | CEO |
| May 3, 1977 | K770455 | GLUCOSE PROCEDURE, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. | CGE |
| May 3, 1977 | K770454 | CREATININE PROCEDURE, TEKPOINT Icn Pharmaceuticals, Inc. | CGX |
| May 3, 1977 | K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE Icn Pharmaceuticals, Inc. | CIO |
| May 3, 1977 | K770452 | PROTEIN PROCEDURE, TEKPOINT TOTAL Icn Pharmaceuticals, Inc. | CEK |
| May 3, 1977 | K770451 | ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL Icn Pharmaceuticals, Inc. | CIX |
| May 3, 1977 | K770450 | CHLORIDE PROCEDURE, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. | CHJ |
| May 3, 1977 | K770449 | CALCIUM PROCEDURE, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. | CIC |
| Apr 29, 1977 | K770459 | URIC ACID PROCEDURE, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. | CDH |
| Apr 5, 1977 | K770319 | REAGENT CPK, ENZYME Icn Pharmaceuticals, Inc. | CGS |
| Apr 5, 1977 | K770318 | REAGENT GOT, ENZYME Icn Pharmaceuticals, Inc. | CIT |
| Apr 5, 1977 | K770315 | BUN, ENZYMATIC Icn Pharmaceuticals, Inc. | CDQ |
| Apr 5, 1977 | K770313 | REAGENT LDH-L, ENZYME Icn Pharmaceuticals, Inc. | CFJ |
| Apr 5, 1977 | K770312 | CHEMISTRY CONTROL, ABNORMAL Icn Pharmaceuticals, Inc. | JJY |
| Apr 5, 1977 | K770310 | CHEMISTRY CONTROL, NORMAL Icn Pharmaceuticals, Inc. | JJY |
| Mar 30, 1977 | K770317 | GLUCOSE TRINDER, ENZYMATIC Icn Pharmaceuticals, Inc. | CGA |
| Mar 30, 1977 | K770316 | ALKALINE PHOSPHATASE ENZYMATIC Icn Pharmaceuticals, Inc. | CJE |
| Mar 30, 1977 | K770314 | REAGENT GPT, ENZYME Icn Pharmaceuticals, Inc. | CKA |
| Mar 30, 1977 | K770311 | GLUCOSE REAGENT, ENZYMATIC Icn Pharmaceuticals, Inc. | CFR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||