FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
IMMUNOCORP COATED TUBE IRMA HCG
K Number: K910349
·
Decision Mar 21, 1991
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
1
Review Days
51
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
- IMMUNOCORP COATED TUBE IRMA HCG
- K Number
- K910349
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immunocorp
- Date Received
- January 29, 1991
- Decision Date
- March 21, 1991
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JHI), ordered by most recent decision date.
Innovita HCG Pregnancy Rapid Combo Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alltest Pregnancy Rapid Combo Test Cassette
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica IM Total hCG (ThCG)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WUNDER PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry