510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Seratronics, Inc.

Mchenry, IL, US

Seratronics, Inc. appears in FDA device records in Mchenry, IL. 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 Seratronics, Inc. between 1982 and 1996. The busiest year on record is 1985, with 4. The most recent is 1996, with 2.

Clearances by year, as a table
510(k) clearance decisions for Seratronics, Inc., by decision year
YearClearances
19821
19831
19841
19854
19864
19873
19882
19921
19941
19951
19962
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K955299DPS 4 DIALYZER PREPARATION SYSTEMLIFSubstantially Equivalent
K931336DRS 4 DIALYZER REPROCESSING SYSTEMLIFSubstantially Equivalent
K944539DRS 4 ND DIALYZER REPROCESSING SYSTEMLIFSubstantially Equivalent
K923529DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCESLIFSubstantially Equivalent
K914580DRS-4 DIALYZER REPROCESSING SYSTEMLIFSubstantially Equivalent
K874573FRESENIUS PURISTERIL 340 (TM)LIFSubstantially Equivalent
K874872FRESENIUS HEMOFLOW F3, F4, F5, F7FJISubstantially Equivalent
K870725FRESENIUS HEMOFLOW F6 AND F8FJISubstantially Equivalent
K870724FRESENIUS HEMOFLOW F60 AND F80KDISubstantially Equivalent
K864587FRESENIUS ULTRAFLUX AV400, AV600KDISubstantially Equivalent
K864169FRESENIUS HEMOFLOW F50 & F70KDISubstantially Equivalent
K861106FRESENIUS HEMOFLOW F80 DIALYZERKDISubstantially Equivalent
K860674DRS-4 DIALYZER REPROCESSING SYSTEMLIFSubstantially Equivalent
K855001FRESENIUS HEMODIALYSIS MACHINE A1008 BSMFLCSubstantially Equivalent
K853851FRESENIUS DISPOSABLE BLOOD LINESFJKSubstantially Equivalent
K852251FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40KDISubstantially Equivalent
K844750FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MODFKQSubstantially Equivalent
K844641FRESENIUS HAEMODIALYSIS ;MACHINE A1008FKQSubstantially Equivalent
K843014FRESENIUS HAEMODIALYSIS A2008KDISubstantially Equivalent
K832230DIALYZER PREPARATION SYS DPS-4LIFSubstantially Equivalent
K821863DIALYZER REPROCESSING SYSTEM DRS-4LIFSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

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