FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SALICYLATES
K Number: K813431
·
Decision Mar 25, 1982
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
28
Applicant Total
19
Review Days
107
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Basic Information
- Device Name
- SALICYLATES
- K Number
- K813431
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3830
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Analytics Laboratories, Inc.
- Date Received
- December 8, 1981
- Decision Date
- March 25, 1982
- Product Code
- DKJ
- 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 |
|---|---|---|---|
| DKJ | Colorimetry, Salicylate | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKJ), ordered by most recent decision date.
ADVIA CHEMISTRY SALICYLATE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SALICYLATE-SL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Bio-Analytics Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861638 | KINETIC ALKALINE PHOSPHATASE REAGENT KIT | May 29, 1986 | Substantially Equivalent |
| K860245 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Mar 14, 1986 | Substantially Equivalent |
| K860213 | ALBUMIN REAGENT KIT | Feb 11, 1986 | Substantially Equivalent |
| K851513 | ULTRA-VIOLET BUN REAGENT KIT | May 20, 1985 | Substantially Equivalent |
| K851514 | ULTRA-VIOLET GLUCOSE REAGENT | May 20, 1985 | Substantially Equivalent |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Mar 5, 1985 | Substantially Equivalent |
| K832771 | ERYTHROCYTE TEST | Oct 28, 1983 | Substantially Equivalent |
| K832567 | ACETAMINOPHEN(PARACETAMOL | Sep 12, 1983 | Substantially Equivalent |
| K831414 | COLORIMETRIC BUN | Jun 16, 1983 | Substantially Equivalent |
| K821934 | BIO-CAL OPERATION CHECK KIT | Jul 20, 1982 | Substantially Equivalent |