Icn Biomedicals, Inc.
Burlingame, CA, US
Icn Biomedicals, Inc. appears in FDA device records in Burlingame, CA. FDA records list 11 510(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
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Icn Biomedicals, Inc. between 1988 and 2003. The busiest year on record is 1992, with 3. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 1 |
| 1995 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K030211 | RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 | DKX | Substantially Equivalent | |
| K023252 | RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 | DJR | Substantially Equivalent | |
| K926106 | IMMUCHEM PHE-MW EA | JNB | Substantially Equivalent | |
| K922944 | IMMUCHEM LH-MW ELISA | CEP | Substantially Equivalent | |
| K922715 | IMMUCHEM PRL-MW ELISA | CFT | Substantially Equivalent | |
| K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | CGJ | Substantially Equivalent | |
| K920442 | IMMUCHEM TSH-MW ELISA | JLW | Substantially Equivalent | |
| K913963 | IMMUCHEM NEONATAL TSH-MP ELISA | JLW | Substantially Equivalent | |
| K902445 | LYMPHO SEP(TM) | JCF | Substantially Equivalent | |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | JLX | Substantially Equivalent | |
| K881005 | IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG | JHI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DJREnzyme Immunoassay, Methadone
- JCFLymphocyte Separation Medium
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- DKXThin Layer Chromatography, Barbiturate
- JHIVisual, Pregnancy Hcg, Prescription Use
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