FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED BETA QUIK STAT EIA KIT
K Number: K882895
·
Decision Oct 12, 1988
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
29
Review Days
93
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
- MODIFIED BETA QUIK STAT EIA KIT
- K Number
- K882895
- 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
- July 11, 1988
- Decision Date
- October 12, 1988
- Product Code
- DHA
- 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 |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHA), ordered by most recent decision date.
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Total ßhCG (5th IS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| K883639 | MODIFIED HCG IRMA KIT | Oct 6, 1988 | Substantially Equivalent |