Company ยท US
Icn Biomedicals, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2003. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 |
| DKX | Thin Layer Chromatography, Barbiturate | 1 |
| JCF | Lymphocyte Separation Medium | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 1 |
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2003 | K030211 | RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 Icn Biomedicals, Inc. | DKX |
| Nov 22, 2002 | K023252 | RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 Icn Biomedicals, Inc. | DJR |
| Feb 8, 1995 | K926106 | IMMUCHEM PHE-MW EA Icn Biomedicals, Inc. | JNB |
| Feb 2, 1993 | K922944 | IMMUCHEM LH-MW ELISA Icn Biomedicals, Inc. | CEP |
| Oct 5, 1992 | K922715 | IMMUCHEM PRL-MW ELISA Icn Biomedicals, Inc. | CFT |
| Oct 5, 1992 | K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT Icn Biomedicals, Inc. | CGJ |
| Mar 18, 1992 | K920442 | IMMUCHEM TSH-MW ELISA Icn Biomedicals, Inc. | JLW |
| Dec 13, 1991 | K913963 | IMMUCHEM NEONATAL TSH-MP ELISA Icn Biomedicals, Inc. | JLW |
| Aug 22, 1990 | K902445 | LYMPHO SEP(TM) Icn Biomedicals, Inc. | JCF |
| Feb 23, 1989 | K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA Icn Biomedicals, Inc. | JLX |
| May 27, 1988 | K881005 | IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG Icn Biomedicals, Inc. | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||