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

Fallbrook, CA, US

International Enzymes, Inc. appears in FDA device records in Fallbrook, CA. FDA records list 7 510(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
7
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 7 510(k) clearances for International Enzymes, Inc. between 1994 and 2001. The busiest year on record is 1995, with 3. The most recent is 2001, with 1.

Clearances by year, as a table
510(k) clearance decisions for International Enzymes, Inc., by decision year
YearClearances
19942
19953
19961
20011
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K011169HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3JJYSubstantially Equivalent
K963085LIQUID IMMUNOLOGY CONTROL LEVEL I, II, IIIJJXSubstantially Equivalent
K953927LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEMDCFSubstantially Equivalent
K953926LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEMDCKSubstantially Equivalent
K950802LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEMJJYSubstantially Equivalent
K944513LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-EJJYSubstantially Equivalent
K944486LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - EJJYSubstantially 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

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