FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
K Number: K855227
·
Decision Apr 11, 1986
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
13
Review Days
102
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Basic Information
- Device Name
- MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
- K Number
- K855227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Bioclinical Systems, Inc.
- Date Received
- December 30, 1985
- Decision Date
- April 11, 1986
- Product Code
- KLS
- 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 |
|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLS), ordered by most recent decision date.
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
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ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
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FDA Class 2
·Clinical Toxicology
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Bioclinical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950196 | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | Jun 30, 1995 | Substantially Equivalent |
| K945911 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS | Apr 4, 1995 | Substantially Equivalent |
| K933122 | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | Feb 9, 1994 | Substantially Equivalent |
| K933121 | MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR | Feb 3, 1994 | Substantially Equivalent |
| K873086 | ROUND 1 | Aug 24, 1987 | Substantially Equivalent |
| K860334 | VISI-CHECK HLH TEST MONOCLONAL | Apr 21, 1986 | Substantially Equivalent |
| K860333 | MICRO-ELISA HLH TEST KIT MONOCLONAL | Apr 21, 1986 | Substantially Equivalent |
| K854059 | MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO | Jan 13, 1986 | Substantially Equivalent |
| K854379 | MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT | Jan 7, 1986 | Substantially Equivalent |
| K850257 | BCS GLUCOSE COLORIMETRIC TEST | Mar 5, 1985 | Substantially Equivalent |