FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COCAINE KIT, TOXI-PAK
K Number: K760401
·
Decision Aug 26, 1976
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
54
Review Days
20
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Basic Information
- Device Name
- COCAINE KIT, TOXI-PAK
- K Number
- K760401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- J.T. Baker Chemical Co.
- Date Received
- August 6, 1976
- Decision Date
- August 26, 1976
- Product Code
- DLN
- 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 |
|---|---|---|---|
| DLN | Hemagglutination, Cocaine Metabolites (Benzoylecgnonine) | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DLN), ordered by most recent decision date.
URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE
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HIM TEST COCAINE
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Other Clearances by J.T. Baker Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K803128 | SERIES 810 PLATELET ANALYZER | Apr 3, 1981 | Substantially Equivalent |
| K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT | Oct 10, 1980 | Substantially Equivalent |
| K802035 | BAKER DIAG. ULTRARATE CO2 REAGENT KIT | Sep 26, 1980 | Substantially Equivalent |
| K801909 | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC | Sep 26, 1980 | Substantially Equivalent |
| K801662 | J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. | Sep 16, 1980 | Substantially Equivalent |
| K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO | Sep 16, 1980 | Substantially Equivalent |
| K801661 | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | Sep 16, 1980 | Substantially Equivalent |
| K801795 | BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. | Sep 16, 1980 | Substantially Equivalent |
| K801362 | ALBUMIN NEPHELOMETRIC ASSAY | Jul 21, 1980 | Substantially Equivalent |
| K801432 | HEMOPEXIN NEPHELOMETRIC ASSAY | Jul 8, 1980 | Substantially Equivalent |