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

Logan, UT, US

Hyclone Laboratories, Inc. appears in FDA device records in Logan, UT. FDA records list 11 510(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
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Hyclone Laboratories, Inc. between 1987 and 1988. The busiest year on record is 1987, with 8. The most recent is 1988, with 3.

Clearances by year, as a table
510(k) clearance decisions for Hyclone Laboratories, Inc., by decision year
YearClearances
19878
19883
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K884654ALPHACALF SERUMKITSubstantially Equivalent
K880471BOVINE CALF SERUM SUPPLEMENTED #A-2159KISSubstantially Equivalent
K880470BOVINE CALF SERUM CATALOG #A-2119KISSubstantially Equivalent
K870938FETAL BOVINE SERUMKISSubstantially Equivalent
K870469DEFINED EQUINE SERUM #A-3311KISSubstantially Equivalent
K870468ADULT BOVINE SERUMKISSubstantially Equivalent
K870467DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151KISSubstantially Equivalent
K870466DEFINED CALF BOVINE SERUM #A-2111KISSubstantially Equivalent
K8704656/40 FETAL BOVINE SERUM #A-1110KISSubstantially Equivalent
K870464CHARACTERIZED FETAL BOVINE SERUM #A-1115KISSubstantially Equivalent
K870463DEFINED FETAL BOVINE SERUM #A-1111KISSubstantially 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