FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
H-I-M-TEST FOR DETECTING HUMAN CHOR. GON
K Number: K800055
·
Decision Jan 29, 1980
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
3
Review Days
19
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- H-I-M-TEST FOR DETECTING HUMAN CHOR. GON
- K Number
- K800055
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technam, Inc.
- Date Received
- January 10, 1980
- Decision Date
- January 29, 1980
- Product Code
- JHJ
- 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JHJ), ordered by most recent decision date.
PREGNACOL PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SAS(TM) DIRECT MONOCLONAL HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCUTEX BETA-HCG TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SAS(TM) MONOCLONAL HCG-SLIDE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIRECT PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry