ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13— 510(k) K885097

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K885097 for ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13, Substantially Equivalent on 1989-01-11. Applicant: Diagnostic Chemicals, Ltd. (Usa).

Clearance details

Applicant
Diagnostic Chemicals, Ltd. (Usa)
Product code
Code LDP
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Monroe, CT, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LDP

product code LDP
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.