FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
K Number: K864993
·
Decision Mar 31, 1987
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
99
Applicant Total
39
Review Days
99
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Basic Information
- Device Name
- QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
- K Number
- K864993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- General Diagnostics
- Date Received
- December 22, 1986
- Decision Date
- March 31, 1987
- Product Code
- DIS
- 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 |
|---|---|---|---|
| DIS | Enzyme Immunoassay, Barbiturate | FDA class 2 | Clinical Toxicology |
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Other Clearances by General Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K882663 | BARBITURATE ENZYME IMMUNOASSAY KIT | Sep 19, 1988 | Substantially Equivalent |
| K872882 | CANNABINOID ENZYME IMMUNOASSAY KIT | Nov 3, 1987 | Substantially Equivalent |
| K871305 | COCAINE METABOLITE ENZYME IMMUNOASSAY KIT | Jun 5, 1987 | Substantially Equivalent |
| K863877 | BENZODIAZEPINE ENZYME IMMUNOASSAY KIT | Mar 12, 1987 | Substantially Equivalent |
| K842307 | GENERAL DIAG. CEFONICID 30MCG ANTIMIC | Jul 20, 1984 | Substantially Equivalent |
| K841465 | GENERAL DIAGNOSTICS PLATELET ANTIBODY | Jul 2, 1984 | Substantially Equivalent |
| K833709 | CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK | Dec 30, 1983 | Substantially Equivalent |
| K832653 | CEFUROXIME 30MCG. SUSCEP DISK | Oct 14, 1983 | Substantially Equivalent |
| K831179 | CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP | May 9, 1983 | Substantially Equivalent |
| K830731 | NETILMICIN 30 MCG ANTIMICROBIAL DISK | Apr 8, 1983 | Substantially Equivalent |