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

Bellingham, WA, US

KENT LABORATORIES, INC. appears in FDA device records in Bellingham, WA. FDA records list 40 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
40
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 40 510(k) clearances for Kent Laboratories, Inc. between 1977 and 1995. The busiest year on record is 1979, with 15. The most recent is 1995, with 4.

Clearances by year, as a table
510(k) clearance decisions for Kent Laboratories, Inc., by decision year
YearClearances
19777
197915
19811
19822
19836
19855
19954
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITJZJSubstantially Equivalent
K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITDAKSubstantially Equivalent
K951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITDBASubstantially Equivalent
K950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITDAYSubstantially Equivalent
K85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2DEBSubstantially Equivalent
K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPLDDBSubstantially Equivalent
K850691ANTISERUM TO HUMAN APOLIPOPROTEIN A-IMSJSubstantially Equivalent
K850690ANTISERUM TO HUMAN APOLIPOPROTEIN BMSJSubstantially Equivalent
K850686ANTISERUM TO HUMAN PREALBUMINJZJSubstantially Equivalent
K831961IMMUNODIFFUSION TEST HUMAN ANTITHROMBINJBQSubstantially Equivalent
K831960TEST FOR HUMAN ALPHA ONE ACID GLYCO-LKLSubstantially Equivalent
K831959RADIAL IMMUNO-TEST FOR HUMAN FACTOR BJZHSubstantially Equivalent
K831958RADIAL IMMUNO-TEST FOR HUMAN C-REACTIDCKSubstantially Equivalent
K831957DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOBDADSubstantially Equivalent
K831956DETERM. SIZE 72 RADIAL-HUMAN IGDCZJSubstantially Equivalent
K823765ANTI SERA TO HUMAN OROSCOMUCOIDDEXSubstantially Equivalent
K822472ANTISERA TO HUMAN FERRITINDBFSubstantially Equivalent
K81161372 DETERMIN. SIZE RADIAL IMMUNOD. TESTDDGSubstantially Equivalent
K790706ANTISERUM TO RABBIT IGG H & L CHAINDFHSubstantially Equivalent
K790713ANTISERUM TO HUMAN HEMOPEXINCZXSubstantially Equivalent
K790711ANTISERA TO HUMAN FRAGMENTDFKSubstantially Equivalent
K790702ANTISERUM, HUMAN, IGG H & L CHAINDEWSubstantially Equivalent
K790708ANTISERUM TO HUMAN IG G FC FRAGMENTSDASSubstantially Equivalent
K790720ANTISERA TO RABBIT IMMUNOGLOBULINDFZSubstantially Equivalent
K790715ANTISERUM TO HUMAN FCDASSubstantially Equivalent
K790714ANTISERUM TO HUMAN CERULOPLASMINDDBSubstantially Equivalent
K790712ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULIDDBSubstantially Equivalent
K790709ANTISERUM TO RABBIT IMMUNOGLOBULINDFZSubstantially Equivalent
K790716ANTISERUM TO HUMAN C-REACTIVE PROTEINSDCNSubstantially Equivalent
K790710ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULINDDYSubstantially Equivalent
K790705ANTISERUM TO HUMAN IGMDAOUnknown
K790704ANTISERUM TO HUMAN IGGDEWUnknown
K790703ANTISERUM, HUMAN, IGACZPUnknown
K771243ANTISERA TO HUMAN FAB FRAGMENTDFKSubstantially Equivalent
K771242ANTISERA TO HUMAN FAB FRAGMENTDDRSubstantially Equivalent
K771144RHODAMINE-CONJUGATED ANTISERUMDBYSubstantially Equivalent
K770670FLOR. CONJUG. HUMAN FAB FRAGMENTDFKSubstantially Equivalent
K770669RHODAMINE-CONJUGATED ANTISERUMDEWSubstantially Equivalent
K770668FLUORESCEIN CONJUGATED ANTISERUMDEWSubstantially Equivalent
K770484FLUOR. CONJUGATED ANTISERUMDEWSubstantially Equivalent

Registered establishments

FDA registered establishments for Kent Laboratories, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30199063019906KENT LABORATORIES, INC.777 Jorgensen Pl, BELLINGHAM, WA 98226 US2026and 49 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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