FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG
K Number: K881005
·
Decision May 27, 1988
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
11
Review Days
79
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Basic Information
- Device Name
- IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG
- K Number
- K881005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Icn Biomedicals, Inc.
- Date Received
- March 9, 1988
- Decision Date
- May 27, 1988
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K030211 | RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 | Jun 13, 2003 | Substantially Equivalent |
| K023252 | RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 | Nov 22, 2002 | Substantially Equivalent |
| K926106 | IMMUCHEM PHE-MW EA | Feb 8, 1995 | Substantially Equivalent |
| K922944 | IMMUCHEM LH-MW ELISA | Feb 2, 1993 | Substantially Equivalent |
| K922715 | IMMUCHEM PRL-MW ELISA | Oct 5, 1992 | Substantially Equivalent |
| K922376 | ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT | Oct 5, 1992 | Substantially Equivalent |
| K920442 | IMMUCHEM TSH-MW ELISA | Mar 18, 1992 | Substantially Equivalent |
| K913963 | IMMUCHEM NEONATAL TSH-MP ELISA | Dec 13, 1991 | Substantially Equivalent |
| K902445 | LYMPHO SEP(TM) | Aug 22, 1990 | Substantially Equivalent |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | Feb 23, 1989 | Substantially Equivalent |