FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HCG IRMA, CAT. NO. CR-1501
K Number: K862007
·
Decision Jul 1, 1986
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
29
Review Days
35
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Basic Information
- Device Name
- HCG IRMA, CAT. NO. CR-1501
- K Number
- K862007
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pacific Biotech, Inc.
- Date Received
- May 27, 1986
- Decision Date
- July 1, 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 Pacific Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924461 | STREP A NEGATIVE CONTROL | Dec 2, 1993 | Substantially Equivalent |
| K902510 | CARDS O.S. MONO | Jul 16, 1990 | Substantially Equivalent |
| K896482 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT | Mar 6, 1990 | Substantially Equivalent |
| K896221 | CARDS O.S.(TM) STREP A | Dec 13, 1989 | Substantially Equivalent |
| K895390 | CARDS O.S. (TM) HCG-URINE | Nov 13, 1989 | Substantially Equivalent |
| K891770 | HCG IRMA II | May 24, 1989 | Substantially Equivalent |
| K884616 | FIRSTDAY EARLY PREGNANCY TESTING KIT II | Jan 13, 1989 | Substantially Equivalent |
| K883742 | MODIFIED TSH IRMA KIT | Jan 3, 1989 | Substantially Equivalent |
| K884007 | CARDS(TM) MONO | Nov 18, 1988 | Substantially Equivalent |
| K882895 | MODIFIED BETA QUIK STAT EIA KIT | Oct 12, 1988 | Substantially Equivalent |