FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEGATIVE URINE CONTROL
K Number: K830834
·
Decision Apr 12, 1983
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
280
Review Days
27
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Basic Information
- Device Name
- NEGATIVE URINE CONTROL
- K Number
- K830834
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Helena Laboratories
- Date Received
- March 16, 1983
- Decision Date
- April 12, 1983
- Product Code
- JJW
- 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 |
|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
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| K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | May 10, 2006 | Substantially Equivalent |
| K050053 | HEMORAM/AGGRAM ANALYZER | Jul 11, 2005 | Substantially Equivalent |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | Feb 19, 2003 | Substantially Equivalent |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | Feb 14, 2003 | Substantially Equivalent |
| K022757 | SPIFE CK KIT, MODEL 3332, 3333 | Oct 11, 2002 | Substantially Equivalent |
| K022455 | SPIFE LD-12 KIT, MODEL 3338 | Oct 1, 2002 | Substantially Equivalent |