FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
K Number: K854059
·
Decision Jan 13, 1986
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
13
Review Days
102
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Basic Information
- Device Name
- MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
- K Number
- K854059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bioclinical Systems, Inc.
- Date Received
- October 3, 1985
- Decision Date
- January 13, 1986
- Product Code
- JHI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
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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 |
| K855227 | MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL | Apr 11, 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 |