FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
K Number: K850079
·
Decision Mar 5, 1985
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
13
Review Days
54
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Basic Information
- Device Name
- NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
- K Number
- K850079
- 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
- January 10, 1985
- Decision Date
- March 5, 1985
- Product Code
- LCX
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 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 |
| 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 |