Biodynamics Corp.
Seattle, WA, US
Biodynamics Corp. appears in FDA device records in Seattle, WA. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Biodynamics Corp. between 1980 and 2006. The busiest year on record is 1982, with 6. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 5 |
| 1982 | 6 |
| 1987 | 2 |
| 1988 | 5 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051675 | BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER | MNW | Substantially Equivalent | |
| K884033 | BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER | DSB | Substantially Equivalent | |
| K881631 | BIODYNAMICS AUTOTRANSFUSION RESERVOIR | CAC | Substantially Equivalent | |
| K881968 | BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER | DSB | Substantially Equivalent | |
| K874361 | BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER | DSB | Substantially Equivalent | |
| K873807 | AUTOTRANSFUSION APPARATUS | CAC | Substantially Equivalent | |
| K874034 | ADR-22 AUTOMATIC DIALYZER REPROCESSOR | LIF | Substantially Equivalent | |
| K870052 | INFUMIX MIXING CONTAINER | KPE | Substantially Equivalent | |
| K822716 | UNIVERSAL CENTRIFUGE | JPI | Substantially Equivalent | |
| K822715 | PLATELET CENTRIFUGE | JQC | Substantially Equivalent | |
| K822422 | BASIC CENTRIFUGE | JQC | Substantially Equivalent | |
| K821741 | URICACID | KNK | Substantially Equivalent | |
| K821091 | ACCUCHEK BG. | CGA | Substantially Equivalent | |
| K820465 | CHEMSTRIP UG | CGA | Substantially Equivalent | |
| K812677 | UNITEST-POTASSIUM | CEJ | Substantially Equivalent | |
| K811189 | CHEMSTRIP L | GHD | Substantially Equivalent | |
| K811680 | ACCUDEX | JJQ | Substantially Equivalent | |
| K810075 | AUTOCLIX | FMK | Substantially Equivalent | |
| K810105 | BCA 1000 | JJQ | Substantially Equivalent | |
| K802842 | SINGLE VIAL LIPASE TEST KIT | CHI | Substantially Equivalent | |
| K802521 | CK-MB(IMMUNOLOGICAL) | JHS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- MNWAnalyzer, Body Composition
- CACApparatus, Autotransfusion
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- KPEContainer, I.V.
- JPIDevice, Hematocrit Measuring
- LIFDialyzer Reprocessing System
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- CGAGlucose Oxidase, Glucose
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DSBPlethysmograph, Impedance
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- GHDTest, Leukocyte Alkaline Phosphatase
- CEJTetraphenyl Borate, Colorimetry, Potassium
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain