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

Walker, MI, US

Gamma Enterprises, Inc. appears in FDA device records in Walker, MI. FDA records list 23 510(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
23
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 23 510(k) clearances for Gamma Enterprises, Inc. between 1977 and 1979. The busiest year on record is 1977, with 18. The most recent is 1979, with 1.

Clearances by year, as a table
510(k) clearance decisions for Gamma Enterprises, Inc., by decision year
YearClearances
197718
19784
19791
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K790578GAMMA SMAC REAGENTSCIGSubstantially Equivalent
K780507SERUM GLUTAMIC-PYRUVIC TRANSAMINASECKCSubstantially Equivalent
K780506CARBON DIOXIDE REAGENTSKMSSubstantially Equivalent
K780505SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASECITSubstantially Equivalent
K780504CREATINE PHOSPHOKINASE (CPK)JHSSubstantially Equivalent
K771843WETTING AGENTSSubstantially Equivalent
K771836LACTATE DEHYDROGENASECFJSubstantially Equivalent
K771832CHLORIDEJFSSubstantially Equivalent
K771838SERUM IRONJIYSubstantially Equivalent
K771834CREATININECGXSubstantially Equivalent
K771839SODIUMJGSSubstantially Equivalent
K771837POTASSIUMCEMSubstantially Equivalent
K771835INORGANIC PHOSPHORUSCEOSubstantially Equivalent
K771829ALKALINE PHOSPHATASECJESubstantially Equivalent
K771844WASH SOLUTIONSSubstantially Equivalent
K771842URIC ACIDCDHSubstantially Equivalent
K771841TOTAL PROTEINCEKSubstantially Equivalent
K771831CALCIUMCICSubstantially Equivalent
K771830BLOOD UREA NITROGEN BUNCDWSubstantially Equivalent
K771828ALBUMINCIXSubstantially Equivalent
K771840TOTAL BILIRUBINCIGSubstantially Equivalent
K771833CHOLESTEROLCGOSubstantially Equivalent
K770082SALONMAY BUSTLINE INCREASERMWZSubstantially 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