FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
K Number: K030211
·
Decision Jun 13, 2003
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
11
Review Days
143
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Basic Information
- Device Name
- RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
- K Number
- K030211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icn Biomedicals, Inc.
- Date Received
- January 21, 2003
- Decision Date
- June 13, 2003
- Product Code
- DKX
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DKX | Thin Layer Chromatography, Barbiturate | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKX), ordered by most recent decision date.
View allOther Clearances by Icn Biomedicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023252 | RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 | Nov 22, 2002 | Substantially Equivalent |
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| K922944 | IMMUCHEM LH-MW ELISA | Feb 2, 1993 | Substantially Equivalent |
| K922715 | IMMUCHEM PRL-MW ELISA | Oct 5, 1992 | Substantially Equivalent |
| K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | Oct 5, 1992 | Substantially Equivalent |
| K920442 | IMMUCHEM TSH-MW ELISA | Mar 18, 1992 | Substantially Equivalent |
| K913963 | IMMUCHEM NEONATAL TSH-MP ELISA | Dec 13, 1991 | Substantially Equivalent |
| K902445 | LYMPHO SEP(TM) | Aug 22, 1990 | Substantially Equivalent |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | Feb 23, 1989 | Substantially Equivalent |
| K881005 | IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG | May 27, 1988 | Substantially Equivalent |