FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYMUN TEST R T3
K Number: K896900
·
Decision Feb 8, 1990
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
143
Applicant Total
340
Review Days
62
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ENZYMUN TEST R T3
- K Number
- K896900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1710
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- December 8, 1989
- Decision Date
- February 8, 1990
- Product Code
- CDP
- 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 |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDP), ordered by most recent decision date.
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHIRON DIAGNOSTICS ACS: 180 FT3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AIA-PACK FT3 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OPTICOAT T3 EIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABBOTT ARCHITECT FREE T3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Boehringer Mannheim Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K984326 | ELECYS IGE ASSAY | Feb 8, 1999 | Substantially Equivalent |
| K983047 | ACCU-CHEK HQ SYSTEM | Feb 5, 1999 | Substantially Equivalent |
| K984419 | ELECSYS IGE CALCHECK | Feb 2, 1999 | Substantially Equivalent |
| K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR | Jan 20, 1999 | Substantially Equivalent |
| K984372 | ELECSYS CALCHECK TROPONIN T | Dec 14, 1998 | Substantially Equivalent |
| K984105 | ELECSYS TROPONIN T STAT TEST | Dec 8, 1998 | Substantially Equivalent |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Dec 1, 1998 | Substantially Equivalent |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | Nov 25, 1998 | Substantially Equivalent |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Nov 12, 1998 | Substantially Equivalent |
| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |