510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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American Laboratory Products Company

Salem, NH, US

American Laboratory Products Company appears in FDA device records in Salem, NH. FDA records list 27 510(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
27
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 27 510(k) clearances for American Laboratory Products Company between 1991 and 2002. The busiest year on record is 1996, with 11. The most recent is 2002, with 1.

Clearances by year, as a table
510(k) clearance decisions for American Laboratory Products Company, by decision year
YearClearances
19911
19941
19957
199611
19972
19982
20012
20021
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K012576CIC-C1Q EIADAKSubstantially Equivalent
K011415ALPCO MILENIA ANTI-TG EIAJZOSubstantially Equivalent
K011201ALPCO MILENIA ANTI-TPO ELISAJZOSubstantially Equivalent
K974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAMOBSubstantially Equivalent
K974701ORGENTEC ANTI-MPO (P-ANCA) ELISAMOBSubstantially Equivalent
K972190THYROGLOBULIN ASSAY SYSTEMJZOSubstantially Equivalent
K970932ORGENTEC MICRO-ALBUMIN EIA ASSAYJIRSubstantially Equivalent
K962062ORGENTEC ANTI-SM ELISALJMSubstantially Equivalent
K962057ORGENTEC ANTI-RNP/SM ELISALJMSubstantially Equivalent
K962055ORGENTEC ANTI-SCL 70 ELISALJMSubstantially Equivalent
K962054ORGENTEC ANTI-SS-A(RO) ELISALJMSubstantially Equivalent
K962053ORGENTEC ANTI-JO-1 ELISALJMSubstantially Equivalent
K962052ORGENTEC ABTI-SS-BB(LA) ELISALJMSubstantially Equivalent
K963911ALPCO/MERCODIA INSULIN ELISACFPSubstantially Equivalent
K962926ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAYMIDSubstantially Equivalent
K962469ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAYMIDSubstantially Equivalent
K955561BUHLMANN VITAMIN B6 REACDDSubstantially Equivalent
K955449ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAYMIDSubstantially Equivalent
K952055ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAYLRMSubstantially Equivalent
K952130ORGENTEC ANTI-TG ELISAJZOSubstantially Equivalent
K952129ORGENTEC ANTI-TPO ELISAJZOSubstantially Equivalent
K950217ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)JZOSubstantially Equivalent
K950090ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)JZOSubstantially Equivalent
K950089ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)JZOSubstantially Equivalent
K950088ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)JZOSubstantially Equivalent
K942497ANGIOTENSIN CONVERTING ENZYME REAKQNSubstantially Equivalent
K913091BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAYKQNSubstantially Equivalent

Registered establishments

FDA registered establishments for American Laboratory Products Company, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12223021000121039American Laboratory Products Company26 Keewaydin Drive, Salem, NH 03079 US2026and 28 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