FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GDS ENZYMATIC ACETAMINOPHEN REAGENT
K Number: K880829
·
Decision May 27, 1988
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
35
Applicant Total
7
Review Days
87
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Basic Information
- Device Name
- GDS ENZYMATIC ACETAMINOPHEN REAGENT
- K Number
- K880829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3030
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Gds Technology, LLC
- Date Received
- March 1, 1988
- Decision Date
- May 27, 1988
- Product Code
- LDP
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LDP | Colorimetry, Acetaminophen | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDP), ordered by most recent decision date.
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ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
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ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
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DIMENSION VISTA FLEX REAGENT CARTRIDGES
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Other Clearances by Gds Technology, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K994073 | HEMOSITE TEST SYSTEM | Jan 14, 2000 | Substantially Equivalent |
| K992132 | CHOLESITE TEST SYSTEM | Aug 20, 1999 | Substantially Equivalent |
| K973649 | HEMOSITE TEST SYSTEM | Aug 31, 1998 | Substantially Equivalent |
| K971145 | GLUCOSITE TEST SYSTEM | Sep 17, 1997 | Substantially Equivalent |
| K911801 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON | Jul 1, 1991 | Substantially Equivalent |
| K882038 | GDS ENZYMATIC SALICYLATE REAGENT | Jun 24, 1988 | Substantially Equivalent |