FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARDS O.S.(TM) STREP A
K Number: K896221
·
Decision Dec 13, 1989
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
29
Review Days
44
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Basic Information
- Device Name
- CARDS O.S.(TM) STREP A
- K Number
- K896221
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Pacific Biotech, Inc.
- Date Received
- October 30, 1989
- Decision Date
- December 13, 1989
- Product Code
- GTZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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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 |
| 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 |
| K883639 | MODIFIED HCG IRMA KIT | Oct 6, 1988 | Substantially Equivalent |