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

Bedford, MA, US

Reference Diagnostics, Inc. appears in FDA device records in Bedford, MA. FDA records list 17 510(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
17
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 17 510(k) clearances for Reference Diagnostics, Inc. between 1990 and 2006. The busiest year on record is 1996, with 2. The most recent is 2006, with 2.

Clearances by year, as a table
510(k) clearance decisions for Reference Diagnostics, Inc., by decision year
YearClearances
19901
19911
19951
19962
19971
19992
20002
20022
20032
20051
20062
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K053291FERRITIN CALIBRATOR SET, CATALOG NO. 8203JITSubstantially Equivalent
K053211RDI HSFERRITIN KITDBFSubstantially Equivalent
K052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETJITSubstantially Equivalent
K030044EXTENDED RANGE HS CRP KIT, CAT NO:9200DCKSubstantially Equivalent
K030772RDI EXTENDED RANGE CRP CALIBRATOR SETJITSubstantially Equivalent
K021609RDI HS CRP KITDCKSubstantially Equivalent
K021607RDI HS CRP CALIBRATOR SETJITSubstantially Equivalent
K000783DIRECT TIBC CALIBRATORJITSubstantially Equivalent
K000781DIRECT TIBC KITJMOSubstantially Equivalent
K990216MAGNETIC TIBC KITJMOSubstantially Equivalent
K984107RDI DIRECT LDL CHOLESTEROL TESTMRRSubstantially Equivalent
K973988RDI HOMOGENEOUS HDL CHOLESTEROL TESTLBSSubstantially Equivalent
K964064RDI LIPIDIRECT MAGNETIC LDL REAGENTMRRSubstantially Equivalent
K964063RDI LDL PRECIPITATION REAGENTMRRSubstantially Equivalent
K944975MAGNETIC HDL CHOLESTEROL TESTLBRSubstantially Equivalent
K911906MAGNETIC HDL CHOLESTEROL TESTLBRSubstantially Equivalent
K893740LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TESMRRSubstantially 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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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain