HCG CONTROL— 510(k) K921206
Substantially EquivalentPolymedco, Inc.
FDA 510(k) clearance K921206 for HCG CONTROL, Substantially Equivalent on 1992-04-29. Applicant: Polymedco, Inc.. Device class: 1.
Clearance details
- Applicant
- Polymedco, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
Recent devices under product code JJX
view allMore clearances from Polymedco, Inc.
view all- K112408 — POLY-CHEM 90 ISE MODULE
- K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
- K111143 — POLY-CHEM 90 TOTAL BILIRUBIN
- K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
- K090703 — POLY-CHEM 90 GLUCOSE
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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.